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The primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in children in African countries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin plus Chloroquine | Drug | Combination of Azithromycin plus Chloroquine Azithromycin (~30 mg/kg) + chloroquine (~10mg base /kg) combination tablet(s) on weight basis, once daily for 3 days (Days 0,1,2) or Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population | ACPR (PCR-corrected) was defined as asexual Plasmodium falciparum (P.falciparum) parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of Early Treatment Failure (ETF) (see measure description in secondary outcome measures 7 and 8) or PCR-corrected Late Treatment Failure (LTF) (which includes PCR-corrected Late Clinical Failures [LCF] - see measure description in secondary outcome measure 9 and 10, and PCR-corrected Late Parasitologic Failures (LPF)- see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | Day 28 |
| Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population | ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With PCR-corrected ACPR in the mITT Population | ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-Corrected LCF- see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Nouna | Burkina Faso | ||||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25881046 | Derived | Chandra R, Ansah P, Sagara I, Sie A, Tiono AB, Djimde AA, Zhao Q, Robbins J, Penali LK, Ogutu B. Comparison of azithromycin plus chloroquine versus artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in children in Africa: a randomized, open-label study. Malar J. 2015 Mar 10;14:108. doi: 10.1186/s12936-015-0620-8. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants were enrolled in 2 cohorts based on different age criteria. All participants in Cohort 1 met the age criteria where as 3 participants enrolled in Cohort 2 were slightly older than 5 years (by less than 2 months).
Participants were recruited in 2 age-based Cohorts. Cohort 1=participants between 5-12 years of age, assumed to have some degree of immunity and at less risk for untoward outcome. After demonstration of successful treatment, safety and tolerability in Cohort 1, participants between >=6 months of age to <=59 months of age were enrolled in Cohort 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Azithromycin + Chloroquine | Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between greater than or equal to (>=) 5 years of age and less than or equal to (<=) 12 years of age. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Artemether-lumefantrine | Drug | Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2) |
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| Days 7, 14, 21, 35, 42 |
| Percentage of Participants With PCR-corrected ACPR in PP Population | ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | Days 7, 14, 21, 35, 42 |
| Percentage of Participants With PCR-uncorrected ACPR in the mITT Population | ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection. | Days 7, 14, 21, 28, 35, 42 |
| Percentage of Participants With PCR-uncorrected ACPR in PP Population | ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection. | Days 7, 14, 21, 28, 35, 42 |
| Percentage of Participants With Early Treatment Failure (ETF) in the mITT Population (PCR-corrected) | ETF defined as participants who met the following criteria:
PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | Day 0 up to Day 3 |
| Percentage of Participants With ETF in PP Population (PCR-corrected) | ETF defined as participants who met the following criteria:
PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | Day 0 up to Day 3 |
| Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected) | LCF included participants who met any of the following criteria:
| Days 7, 14, 21, 28, 35, 42 |
| Percentage of Participants With LCF in PP Population (PCR-corrected) | LCF included participants who met any of the following criteria:
| Days 7, 14, 21, 28, 35, 42 |
| Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected) | LPF: Presence of P. falciparum parasitemia in the mITT population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | Days 7, 14, 21, 28, 35, 42 |
| Percentage of Participants With LPF in PP Population (PCR-corrected) | LPF: Presence of P.falciparum parasitemia in the PP population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | Days 7, 14, 21, 28, 35, 42 |
| Percentage of Participants With Asexual Parasitologic Response (PCR-corrected) | Percentage of participants who were cleared of asexual parasites. Asexual parasite clearance - clearance of asexual P.falciparum parasitemia within 7 days of initiation of treatment without subsequent recurrence (PCR-corrected) through the day of consideration. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | Day 7, 14, 21, 28, 35, 42 |
| Percentage of Participants With Gametocytologic Response | Gametocyte response/absence/clearance: Clearance of P.falciparum gametocytemia (PCR-uncorrected) (attainment of 2 consecutive zero gametocyte counts) without subsequent recurrence through the day of consideration. PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection. | Days 7, 14, 21, 28, 35, 42 |
| Fever Clearance Time | Calculated as time of first occurrence of two consecutive time points with temperature less than (<) 38.0 degrees C/100.4 degrees Fahrenheit (F) (rectal), 37.2 degrees C/99.0 degrees F (axillary), or <37.5 degrees C/99.5 degrees F (oral). | Baseline to Day 42 |
| Asexual Plasmodium Falciparum Parasite Clearance Time | Defined as time to first of two consecutive zero asexual P. falciparum parasite (PCR-corrected) counts, regardless of recurrence of parasitemia later. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | Baseline to Day 42 |
| Nadir Hemoglobin Level | Nadir hemoglobin for each participant was defined as the minimum hemoglobin values obtained from Day 0 through Day 3. | Day 0 through Day 3 |
| Change From Nadir Hemoglobin Level at Days 14, 28, and 42 | Change from nadir = observation minus nadir. Nadir defined as the minimum value for each participant on Days 0-3. | Day 14, 28, 42 |
| Time to Recurrence of Parasitemia | Time from the day of clearance to the time of recurrence of asexual P.falciparum parasitemia (PCR-uncorrected). | Baseline (Day 0) to Day 42 |
| Number of Participants With Recurrent Parasitemia Versus Baseline Plasmodium Falciparum Chloroquine Resistance Transporter (PfCRT) Status | Baseline to Day 42 |
| Percentage of Participants With PfCRT in True Failures | A genetic marker, P.falciparum chloroquine resistance transporter (PfCRT), indicative of P.falciparum chloroquine resistance was to be determined from blood blots obtained on Day 0 and at the time of treatment failure. Treatment failure was defined as any of the following events that a participant experienced from Day 0 through the Day 42 visit: ETF (see measure description in secondary outcome measures 7 and 8), LCF (PCR corrected) (see measure description in secondary outcome measure 9 and 10), or LPF (PCR corrected) (see measure description in secondary outcome measure 11 and 12). Recrudescence of asexual P.falciparum parasites was considered treatment failure. | Baseline to Day 42 |
| Ouagadougou |
| Burkina Faso |
| Pfizer Investigational Site | Abidjan | Côte d’Ivoire |
| Pfizer Investigational Site | Navrongo | Ghana |
| Pfizer Investigational Site | Kisumu | 40100 | Kenya |
| Pfizer Investigational Site | Bamako | West Africa | Mali |
| Pfizer Investigational Site | Sikasso | West Africa | Mali |
| FG001 | Cohort 1: Artemether + Lumefantrine | Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between >=5 years of age and <=12 years of age. |
| FG002 | Cohort 2: Azithromycin + Chloroquine | Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age. |
| FG003 | Cohort 2: Artemether + Lumefantrine | Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Azithromycin + Chloroquine | Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between >=5 years of age and <=12 years of age. |
| BG001 | Cohort 1: Artemether + Lumefantrine | Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between >=5 years of age and <=12 years of age. |
| BG002 | Cohort 2: Azithromycin + Chloroquine | Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age. |
| BG003 | Cohort 2: Artemether + Lumefantrine | Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population | ACPR (PCR-corrected) was defined as asexual Plasmodium falciparum (P.falciparum) parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of Early Treatment Failure (ETF) (see measure description in secondary outcome measures 7 and 8) or PCR-corrected Late Treatment Failure (LTF) (which includes PCR-corrected Late Clinical Failures [LCF] - see measure description in secondary outcome measure 9 and 10, and PCR-corrected Late Parasitologic Failures (LPF)- see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | mITT:treated participants who met disease criteria(blood smears positive for P.falciparum monoinfection;asexual parasitemia=1000-100,000 parasites/microliter [mcL];fever/history of fever >=38 degree Celsius[C] [rectal],37.2 degree C [axillary] or >=37.5 degree C [oral] within last 24 hours).Participants in Ivory Coast center excluded from analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 28 |
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| Primary | Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population | ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | Per-Protocol (PP) population was a subset of the mITT population, who received all 3 days of study medication to which they were assigned. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from PP population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 28 |
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| Secondary | Percentage of Participants With PCR-corrected ACPR in the mITT Population | ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-Corrected LCF- see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from mITT population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Days 7, 14, 21, 35, 42 |
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| Secondary | Percentage of Participants With PCR-corrected ACPR in PP Population | ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Days 7, 14, 21, 35, 42 |
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| Secondary | Percentage of Participants With PCR-uncorrected ACPR in the mITT Population | ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection. | mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from mITT population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Days 7, 14, 21, 28, 35, 42 |
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| Secondary | Percentage of Participants With PCR-uncorrected ACPR in PP Population | ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection. | PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Days 7, 14, 21, 28, 35, 42 |
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| Secondary | Percentage of Participants With Early Treatment Failure (ETF) in the mITT Population (PCR-corrected) | ETF defined as participants who met the following criteria:
PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | mITT population, participants in Ivory Coast center were excluded from mITT population. | Posted | Number | Percentage of participants | Day 0 up to Day 3 |
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| Secondary | Percentage of Participants With ETF in PP Population (PCR-corrected) | ETF defined as participants who met the following criteria:
PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | PP population, participants in Ivory Coast center were excluded from the PP population. | Posted | Number | Percentage of participants | Day 0 up to Day 3 |
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| Secondary | Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected) | LCF included participants who met any of the following criteria:
| mITT population, participants in Ivory Coast center were excluded from mITT population. | Posted | Number | Percentage of participants | Days 7, 14, 21, 28, 35, 42 |
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| Secondary | Percentage of Participants With LCF in PP Population (PCR-corrected) | LCF included participants who met any of the following criteria:
| PP population, participants in Ivory Coast center were excluded from the PP population. | Posted | Number | Percentage of participants | Days 7, 14, 21, 28, 35, 42 |
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| Secondary | Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected) | LPF: Presence of P. falciparum parasitemia in the mITT population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | mITT population, participants in Ivory Coast center were excluded from mITT population. | Posted | Number | Percentage of participants | Days 7, 14, 21, 28, 35, 42 |
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| Secondary | Percentage of Participants With LPF in PP Population (PCR-corrected) | LPF: Presence of P.falciparum parasitemia in the PP population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | PP population, participants in Ivory Coast center were excluded from the PP population. | Posted | Number | Percentage of participants | Days 7, 14, 21, 28, 35, 42 |
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| Secondary | Percentage of Participants With Asexual Parasitologic Response (PCR-corrected) | Percentage of participants who were cleared of asexual parasites. Asexual parasite clearance - clearance of asexual P.falciparum parasitemia within 7 days of initiation of treatment without subsequent recurrence (PCR-corrected) through the day of consideration. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | mITT population. Number of participants analyzed (N)=participants with evaluable data, including participants in the Ivory Coast center. "n"=participants who were evaluable at specified time points for each arm, respectively. | Posted | Number | Percentage of participants | Day 7, 14, 21, 28, 35, 42 |
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| Secondary | Percentage of Participants With Gametocytologic Response | Gametocyte response/absence/clearance: Clearance of P.falciparum gametocytemia (PCR-uncorrected) (attainment of 2 consecutive zero gametocyte counts) without subsequent recurrence through the day of consideration. PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection. | mITT population. "N"= participants with evaluable data, including participants in the Ivory Coast center. "n"=participants who were evaluable at specified time points for each arm, respectively. | Posted | Number | Percentage of participants | Days 7, 14, 21, 28, 35, 42 |
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| Secondary | Fever Clearance Time | Calculated as time of first occurrence of two consecutive time points with temperature less than (<) 38.0 degrees C/100.4 degrees Fahrenheit (F) (rectal), 37.2 degrees C/99.0 degrees F (axillary), or <37.5 degrees C/99.5 degrees F (oral). | mITT population, including participants in the Ivory Coast center. | Posted | Median | Full Range | Hours | Baseline to Day 42 |
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| Secondary | Asexual Plasmodium Falciparum Parasite Clearance Time | Defined as time to first of two consecutive zero asexual P. falciparum parasite (PCR-corrected) counts, regardless of recurrence of parasitemia later. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. | mITT population, including participants in the Ivory Coast center. | Posted | Median | Full Range | Hours | Baseline to Day 42 |
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| Secondary | Nadir Hemoglobin Level | Nadir hemoglobin for each participant was defined as the minimum hemoglobin values obtained from Day 0 through Day 3. | mITT population, including participants in the Ivory Coast center. | Posted | Mean | Standard Deviation | grams per deciliter (g/dL) | Day 0 through Day 3 |
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| Secondary | Change From Nadir Hemoglobin Level at Days 14, 28, and 42 | Change from nadir = observation minus nadir. Nadir defined as the minimum value for each participant on Days 0-3. | mITT population. "N" = number of participants with evaluable data, including participants in the Ivory Coast center. "n"=participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Error | g/dL | Day 14, 28, 42 |
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| Secondary | Time to Recurrence of Parasitemia | Time from the day of clearance to the time of recurrence of asexual P.falciparum parasitemia (PCR-uncorrected). | mITT population, including participants in the Ivory Coast center. | Posted | Median | Full Range | Days | Baseline (Day 0) to Day 42 |
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| Secondary | Number of Participants With Recurrent Parasitemia Versus Baseline Plasmodium Falciparum Chloroquine Resistance Transporter (PfCRT) Status | Data for this outcome measure was not analyzed as per change in planned analysis. | Posted | Baseline to Day 42 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With PfCRT in True Failures | A genetic marker, P.falciparum chloroquine resistance transporter (PfCRT), indicative of P.falciparum chloroquine resistance was to be determined from blood blots obtained on Day 0 and at the time of treatment failure. Treatment failure was defined as any of the following events that a participant experienced from Day 0 through the Day 42 visit: ETF (see measure description in secondary outcome measures 7 and 8), LCF (PCR corrected) (see measure description in secondary outcome measure 9 and 10), or LPF (PCR corrected) (see measure description in secondary outcome measure 11 and 12). Recrudescence of asexual P.falciparum parasites was considered treatment failure. | Data for this outcome measure was not analyzed as per change in planned analysis. | Posted | Baseline to Day 42 |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Azithromycin + Chloroquine | Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base). Cohort 1 included participants between >=5 years of age and <=12 years of age. | 1 | 55 | 40 | 55 | ||
| EG001 | Cohort 1: Artemether + Lumefantrine | Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between >=5 years of age and <=12 years of age. | 2 | 51 | 36 | 51 | ||
| EG002 | Cohort 2: Azithromycin + Chloroquine | Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age. | 0 | 124 | 103 | 124 | ||
| EG003 | Cohort 2: Artemether + Lumefantrine | Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age. | 1 | 131 | 99 | 131 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatitis B | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Conjunctival pallor | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Dysentery | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Giardiasis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Infection parasitic | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Tinea capitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Anal pruritus | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Mucous stools | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Product taste abnormal | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Amoebiasis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Blister infected | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Helminthic infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Mumps | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Septic rash | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Vaginal inflammation | Reproductive system and breast disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
Cohort 1 was a screening cohort, meant for safety evaluation, but not included in the efficacy assessments.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D002738 | Chloroquine |
| D000077611 | Artemether, Lumefantrine Drug Combination |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000077549 | Artemether |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D000078102 | Lumefantrine |
| D005449 | Fluorenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| 5 years - 12 years |
|
| Male |
|
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age. |
|
|
|
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
|
|
|
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
|
|
|
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
|
|
|
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
|
|
|
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age. |
|
|
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age. |
|
|
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age. |
|
|
Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
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