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The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin plus chloroquine | Experimental | Single Arm, Open label study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin plus chloroquine | Drug | dose of 2000 mg Azithromycin plus 600 mg chloroquine base |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Parasite Clearance at Day 28 | Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here "N" (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Early Treatment Failures (ETF) | ETF was defined as a participant meeting any of these criteria: development of signs of severe malaria (impaired consciousness [for example, obtundation, unarousable coma, delirium, stupor], respiratory distress [respiratory rate greater than or equal to {>=} 30 breaths/minute], seizures, hypoglycemia [glucose less than or equal to {<=} 40 milligram/deciliter], gross hematuria, increase in parasitemia to greater than 100,000 parasites/microliter in 48 hours or later after the first treatment dose was administered) any day from Day 0 to 3 in the presence of P falciparum parasitemia; parasite count on Day 2 > Day 0 (baseline), irrespective of axillary or oral temperature; parasite count on Day 3 > 37.5 degrees Celsius (axillary temperature) and >38 degrees Celsius (oral temperature) and parasite count on Day 3 >=25 percent (%) of the first available parasite density on Day 0 (baseline). |
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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 | Tumaco | Departamento de Nariño | Colombia | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Azithromycin and Chloroquine | Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All treated population included participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Azithromycin and Chloroquine | Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Parasite Clearance at Day 28 | Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here "N" (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28. | Parasitological per protocol (PP) population: Participants who had study drug for 3 days unless treatment failure, no concomitant anti-malarial unless designated treatment failure, had test of cure at Day 28, baseline smear with parasitemia between 1000-100000 parasites/microliter, rapid diagnostic test positive for P falciparum, history of fever. | Posted | Number | 90% Confidence Interval | percentage of participants | Day 28 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azithromycin and Chloroquine | Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v11.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D002738 | Chloroquine |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Baseline up to Day 28 |
| Percentage of Participants With Late Treatment Failures (LTF) | LTF included late clinical failure (LCF) and late parasitologic failure (LPF). LCF is defined as a participant meeting any of these criteria: development of signs or symptoms of severe malaria after Day 3 in the presence of P falciparum parasitemia, without previously meeting any of the criteria of ETF or presence of P falciparum parasitemia and fever or history of fever on any day from Day 4 to Day 28, without previously meeting any of the criteria of ETF. LPF is defined as presence of P falciparum parasitemia on any day from Day 7 to Day 28 and the absence of fever or history of fever without previously meeting any of the criteria of ETF or LCF. | Baseline up to Day 28 |
| Percentage of Participants With Resistance to Treatment | Resistance is measured by clearance of asexual P falciparum parasitemia and categorized into 3 levels; resistance I (RI): clearance of asexual P. falciparum parasitemia before Day 7 followed by recurrence on or after Day 7, resistance II (RII): marked reduction (<=25% of baseline) of asexual P. falciparum parasitemia but no clearance prior to and up to Day 7, and resistance III (RIII): no marked reduction (>25% of baseline) of asexual P. falciparum parasitemia. Recurrence was defined as the reappearance of asexual P. falciparum parasitemia following a quiescent or latent period after the cessation of the primary attack. Percentage of participants with resistance as measured by RI, RII and RIII is reported. | Days 7, 14, 21, 28, 35, 42 |
| Percentage of Participants With Clinical Cure | Clinical Cure is defined as resolution of the participant's fever and other symptoms attributed to P falciparum malaria (for example, abdominal pain, malaise, and headache). | Day 3, 7, 28, and 42 |
| Percentage of Participants With Parasite Clearance at Day 7, 14, 21, 35, 42 | Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here "N" (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28. | Day 7, 14, 21, 35, 42 |
| Percentage of Participants With Gametocyte Clearance | Gametocyte clearance was defined as clearance of P falciparum gametocytemia (defined as attainment of 3 consecutive 0 gametocyte counts) without subsequent recurrence through the day of consideration. Recurrence was defined as the reappearance of asexual P. falciparum gametocytemia after achieving clearance. Percentage of participants with gametocyte clearance were reported. | Day 7, 14, 21, 28, 35, 42 |
| Fever Clearance Time | Fever clearance time (FCT) was defined as the time from baseline to the first of 2 consecutive time points with temperature less than (<) 37.5 degree Celsius (C) (axillary temperature) or <38 degree C (oral temperature). | Baseline up to Day 42 |
| Parasite Clearance Time | Asexual P falciparum parasite clearance time was defined as the time from baseline to the first of the 3 consecutive 0 parasite counts. | Baseline up to Day 42 |
| Bambolim |
| Goa |
| 403002 |
| India |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Azithromycin and Chloroquine | Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days. |
|
|
| Secondary | Percentage of Participants With Early Treatment Failures (ETF) | ETF was defined as a participant meeting any of these criteria: development of signs of severe malaria (impaired consciousness [for example, obtundation, unarousable coma, delirium, stupor], respiratory distress [respiratory rate greater than or equal to {>=} 30 breaths/minute], seizures, hypoglycemia [glucose less than or equal to {<=} 40 milligram/deciliter], gross hematuria, increase in parasitemia to greater than 100,000 parasites/microliter in 48 hours or later after the first treatment dose was administered) any day from Day 0 to 3 in the presence of P falciparum parasitemia; parasite count on Day 2 > Day 0 (baseline), irrespective of axillary or oral temperature; parasite count on Day 3 > 37.5 degrees Celsius (axillary temperature) and >38 degrees Celsius (oral temperature) and parasite count on Day 3 >=25 percent (%) of the first available parasite density on Day 0 (baseline). | Parasitologic PP population. Here, "N" (Number of participants analyzed) signifies those who were evaluable for this outcome measure. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline up to Day 28 |
|
|
|
| Secondary | Percentage of Participants With Late Treatment Failures (LTF) | LTF included late clinical failure (LCF) and late parasitologic failure (LPF). LCF is defined as a participant meeting any of these criteria: development of signs or symptoms of severe malaria after Day 3 in the presence of P falciparum parasitemia, without previously meeting any of the criteria of ETF or presence of P falciparum parasitemia and fever or history of fever on any day from Day 4 to Day 28, without previously meeting any of the criteria of ETF. LPF is defined as presence of P falciparum parasitemia on any day from Day 7 to Day 28 and the absence of fever or history of fever without previously meeting any of the criteria of ETF or LCF. | Parasitologic PP population. Here, "N" (Number of participants analyzed) signifies those who were evaluable for this outcome measure. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline up to Day 28 |
|
|
|
| Secondary | Percentage of Participants With Resistance to Treatment | Resistance is measured by clearance of asexual P falciparum parasitemia and categorized into 3 levels; resistance I (RI): clearance of asexual P. falciparum parasitemia before Day 7 followed by recurrence on or after Day 7, resistance II (RII): marked reduction (<=25% of baseline) of asexual P. falciparum parasitemia but no clearance prior to and up to Day 7, and resistance III (RIII): no marked reduction (>25% of baseline) of asexual P. falciparum parasitemia. Recurrence was defined as the reappearance of asexual P. falciparum parasitemia following a quiescent or latent period after the cessation of the primary attack. Percentage of participants with resistance as measured by RI, RII and RIII is reported. | Parasitologic PP population. Here, "N" (Number of participants analyzed) signifies those who were evaluable for this outcome measure and "n" signifies number of participants who were evaluated at given time point. | Posted | Number | percentage of participants | Days 7, 14, 21, 28, 35, 42 |
|
|
|
| Secondary | Percentage of Participants With Clinical Cure | Clinical Cure is defined as resolution of the participant's fever and other symptoms attributed to P falciparum malaria (for example, abdominal pain, malaise, and headache). | Parasitologic PP population. Here, "N" (Number of participants analyzed) signifies those who were evaluable for this outcome measure. | Posted | Number | 90% Confidence Interval | percentage of participants | Day 3, 7, 28, and 42 |
|
|
|
| Secondary | Percentage of Participants With Parasite Clearance at Day 7, 14, 21, 35, 42 | Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here "N" (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28. | Parasitologic PP population. Here, "N" (Number of participants analyzed) signifies those participants who were evaluable for this outcome measure and "n" signifies number of participants who were evaluated at given time point. | Posted | Number | 90% Confidence Interval | percentage of participants | Day 7, 14, 21, 35, 42 |
|
|
|
| Secondary | Percentage of Participants With Gametocyte Clearance | Gametocyte clearance was defined as clearance of P falciparum gametocytemia (defined as attainment of 3 consecutive 0 gametocyte counts) without subsequent recurrence through the day of consideration. Recurrence was defined as the reappearance of asexual P. falciparum gametocytemia after achieving clearance. Percentage of participants with gametocyte clearance were reported. | Parasitologic PP population. Here, "N" (Number of participants analyzed) signifies those who were evaluable for this outcome measure and "n" signifies number of participants who were evaluated at given time point. | Posted | Number | 90% Confidence Interval | percentage of participants | Day 7, 14, 21, 28, 35, 42 |
|
|
|
| Secondary | Fever Clearance Time | Fever clearance time (FCT) was defined as the time from baseline to the first of 2 consecutive time points with temperature less than (<) 37.5 degree Celsius (C) (axillary temperature) or <38 degree C (oral temperature). | Data not possible to report, as clearance time was obtained as life table plots only, as per planned analysis. | Posted | Baseline up to Day 42 |
|
|
| Secondary | Parasite Clearance Time | Asexual P falciparum parasite clearance time was defined as the time from baseline to the first of the 3 consecutive 0 parasite counts. | Data not possible to report, as clearance time was obtained as life table plots only, as per planned analysis. | Posted | Baseline up to Day 42 |
|
|
| 0 |
| 110 |
| 54 |
| 110 |
| Tachycardia | Cardiac disorders | MedDRA v11.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA v11.1 | Non-systematic Assessment |
|
| Vaginitis bacterial | Infections and infestations | MedDRA v11.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA v11.1 | Non-systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA v11.1 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA v11.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA v11.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA v11.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v11.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
|
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.
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| Organic Chemicals |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Day 28 (n=107) |
|
| Day 35 (n=107) |
|
| Day 42 (n=107) |
|
| Title | Measurements |
|---|---|
|
| Day 42 |
|
| Title | Measurements |
|---|---|
|
| Day 35 (n=107) |
|
| Day 42 (n=107) |
|
| Title | Measurements |
|---|---|
|
| Day 28 (n=105) |
|
| Day 35 (n=103) |
|
| Day 42 (n=104) |
|