Trial · NCT01103713
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication | Day 28 | 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. |
| Primary | Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication | Day 28 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | Parasite counts (actual counts per microliter of blood) was measured at various time points. |
| Other | Summary of Pregnancy Outcome: Location of Delivery | Following delivery or pregnancy termination | All participants were followed up for exposure-in-utero (EIU) safety assessments following delivery or termination of pregnancy. |
| Other | Summary of Pregnancy Outcome: Mode of Delivery | Following delivery or pregnancy termination | All participants were followed up for EIU safety assessments following delivery or termination of pregnancy. |
| Other | Summary of Pregnancy Outcome: Delivery Assisted by Trained Obstetric Personnel? | Following delivery or pregnancy termination | All participants were followed up for EIU safety assessments following delivery or termination of pregnancy. |
| Other | Summary of Pregnancy Outcome: Labor Induced? | Following delivery or pregnancy termination | All participants were followed up for EIU safety assessments following delivery or termination of pregnancy. |
| Other | Summary of Pregnancy Outcome: Complications During Delivery? | Following delivery or pregnancy termination | All participants were followed up for EIU safety assessments following delivery or termination of pregnancy. |
| Other | Summary of Pregnancy Outcome: Outcome of Birth | Following delivery or pregnancy termination | All participants were followed up for EIU safety assessments following delivery or termination of pregnancy. |
| Other | Incidence of Fever Based on Oral Temperature | Baseline, Days 1, 2, 7, 14, 21, 28, 35, and 42 | Oral temp was taken by the fieldworker through Day 42. |
| Other | Summary of Hemoglobin Concentration: Abnormal Hemoglobin Level | Day 42 | 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. |
| Other | 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. | AZ concentrations in the serum was determined at specified time points as PK endpoints |
| Other | Summary of Plasma Chloroquine Concentration Versus Time | 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. | CQ concentrations in the plasma were determined at specified time points as PK endpoints |
| Other | Summary of Plasma Desethylchloroquine Concentration Versus Time | 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. | CQ concentrations in the plasma were determined at specified time points as PK endpoints |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT01103713/registered