| Primary | Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication | The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure. | MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2). |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00099.35(97.76 to 100.00)
|
|
| |
| Primary | Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication | The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure. | PP population was used. PP is a subset of MITT population who had received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2). |
| |
| Secondary | Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication | The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure. | MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Days 7, 14, 21, 35, and 42 | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin/Chloroquine (AZCQ) | This is an open label, single arm study conducted in pregnant women during their second and third trimesters of pregnancy. Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2). |
| |
| Secondary | Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication | The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure. | PP population was used. PP is a subset of MITT population who had received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Days 7, 14, 21, 35, and 42 | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Secondary | Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure. | ITT population was used. ITT is defined as all participants who received at least one dose of study medication and who had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Days 7, 14, 21, 28, 35, and 42 | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Secondary | Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure. | MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Days 7, 14, 21, 28, 35, and 42 | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Secondary | Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure. | PP population was used. PP is a subset of MITT population who received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Days 7, 14, 21, 28, 35, and 42 | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Secondary | Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure. | ITT population was used. ITT is defined as all participants who received at least one dose of study medication and had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Days 7, 14, 21, 28, 35, and 42 | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Secondary | Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | Parasite counts (actual counts per microliter of blood) was measured at various time points. | ITT population was used. ITT is defined as all participants who received at least one dose of study medication and had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Posted | | Mean | Standard Error | Parasite count per microliter | | Days 7, 14, 21, 28, 35, and 42 | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Secondary | Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | Parasite counts (actual counts per microliter of blood) was measured at various time points. | MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Posted | | Mean | Standard Error | Parasite count per microliter | | Days 7, 14, 21, 28, 35, and 42 | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Secondary | Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | Parasite counts (actual counts per microliter of blood) was measured at various time points. | PP population was used. PP is a subset of MITT population who received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Posted | | Mean | Standard Error | Parasite count per microliter | | Days 7, 14, 21, 28, 35, and 42 | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Other Pre-specified | Summary of Pregnancy Outcome: Location of Delivery | All participants were followed up for exposure-in-utero (EIU) safety assessments following delivery or termination of pregnancy. | The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only. | Posted | | Number | | Participants | | Following delivery or pregnancy termination | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Other Pre-specified | Summary of Pregnancy Outcome: Mode of Delivery | All participants were followed up for EIU safety assessments following delivery or termination of pregnancy. | The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only. | Posted | | Number | | Participants | | Following delivery or pregnancy termination | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Other Pre-specified | Summary of Pregnancy Outcome: Delivery Assisted by Trained Obstetric Personnel? | All participants were followed up for EIU safety assessments following delivery or termination of pregnancy. | The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 159 participants only. | Posted | | Number | | Participants | | Following delivery or pregnancy termination | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Other Pre-specified | Summary of Pregnancy Outcome: Labor Induced? | All participants were followed up for EIU safety assessments following delivery or termination of pregnancy. | The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 158 participants only. | Posted | | Number | | Participants | | Following delivery or pregnancy termination | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Other Pre-specified | Summary of Pregnancy Outcome: Complications During Delivery? | All participants were followed up for EIU safety assessments following delivery or termination of pregnancy. | The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 159 participants only. | Posted | | Number | | Participants | | Following delivery or pregnancy termination | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Other Pre-specified | Summary of Pregnancy Outcome: Outcome of Birth | All participants were followed up for EIU safety assessments following delivery or termination of pregnancy. | The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only. | Posted | | Number | | Participants | | Following delivery or pregnancy termination | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Other Pre-specified | Incidence of Fever Based on Oral Temperature | Oral temp was taken by the fieldworker through Day 42. | ITT is defined as all participants who received at least one dose of study medication and who had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process. | Posted | | Number | | Participants | | Baseline, Days 1, 2, 7, 14, 21, 28, 35, and 42 | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Other Pre-specified | Summary of Hemoglobin Concentration: Abnormal Hemoglobin Level | Abnormal hemoglobin level on Day 42 was measured. The hemoglobin levels were measured with HemoCueTM, via finger stick or peripheral blood collection. The reference range was 10-16g/dL. Any value <0.8 times lower limit of normal was considered clinically significant. | The safety analysis set consists of participants who received at least one dose of study medication. | Posted | | Number | | Participants | | Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Other Pre-specified | Summary of Serum Azithromycin Concentration Versus Time | AZ concentrations in the serum was determined at specified time points as PK endpoints | Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis. | Posted | | Mean | Standard Deviation | ng/ml | | Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), and 336 (Day 14) hours post the first dose. Note: Assuming "hour not specified" as 0 hours on Day 7 and Day 14 for planned time post first dose calculation. | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Other Pre-specified | Summary of Plasma Chloroquine Concentration Versus Time | CQ concentrations in the plasma were determined at specified time points as PK endpoints | Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis. | Posted | | Mean | Standard Deviation | ng/ml | | Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming "hour not specified" as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation. | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |
| Other Pre-specified | Summary of Plasma Desethylchloroquine Concentration Versus Time | CQ concentrations in the plasma were determined at specified time points as PK endpoints | Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis. | Posted | | Mean | Standard Deviation | ng/ml | | Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming "hour not specified" as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation. | | | | ID | Title | Description |
|---|
| OG000 | Azithromycin (AZ)/Chloroquine (CQ) | Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2) |
| |