Trial · NCT01103713
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication | Day 28 | 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. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication | Day 28 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication | Days 7, 14, 21, 35, and 42 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication | Days 7, 14, 21, 35, and 42 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | Days 7, 14, 21, 28, 35, and 42 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | Days 7, 14, 21, 28, 35, and 42 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | Days 7, 14, 21, 28, 35, and 42 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication | Days 7, 14, 21, 28, 35, and 42 | 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. | Percentage of participants | NUMBER |
| 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 | Days 7, 14, 21, 28, 35, and 42 | 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. | Parasite count per microliter | MEAN |
| 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 | Days 7, 14, 21, 28, 35, and 42 | 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. | Parasite count per microliter | MEAN |
| 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 | Days 7, 14, 21, 28, 35, and 42 | 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. | Parasite count per microliter | MEAN |
| OTHER_PRE_SPECIFIED | Summary of Pregnancy Outcome: Location of Delivery | Following delivery or pregnancy termination | The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Summary of Pregnancy Outcome: Mode of Delivery | Following delivery or pregnancy termination | The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Summary of Pregnancy Outcome: Delivery Assisted by Trained Obstetric Personnel? | Following delivery or pregnancy termination | The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 159 participants only. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Summary of Pregnancy Outcome: Labor Induced? | Following delivery or pregnancy termination | The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 158 participants only. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Summary of Pregnancy Outcome: Complications During Delivery? | Following delivery or pregnancy termination | The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 159 participants only. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Summary of Pregnancy Outcome: Outcome of Birth | Following delivery or pregnancy termination | The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Incidence of Fever Based on Oral Temperature | Baseline, Days 1, 2, 7, 14, 21, 28, 35, and 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. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Summary of Hemoglobin Concentration: Abnormal Hemoglobin Level | Day 42 | The safety analysis set consists of participants who received at least one dose of study medication. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Summary of Serum Azithromycin Concentration Versus Time | 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. | 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. | ng/ml | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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