Trial · NCT00379821
Outcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Clinical Malaria Episodes Per Year of Follow-up | 1 year | The intention to treat (ITT) population was used for the primary outcome. | Episodes per PYAR | NUMBER |
| SECONDARY | Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Day 28 of initial malaria episode (Episode 0) | This analysis was per protocol, which excludes participants who did not have p. falciparum or who did not receive all 3 doses of treatment. | Participants | NUMBER |
| SECONDARY | Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Day 28 of first subsequent malaria episode (Episode 1) | This analysis was per protocol, which includes participants who had at least 1 subsequent malaria episode, but excludes participants who did if that episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the first subsequent episode. | Participants | NUMBER |
| SECONDARY | Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Day 28 of second subsequent malaria episode (Episode 2) | This analysis was per protocol, which which includes participants who had at least 2 subsequent malaria episodes, but excludes participants if the second episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the second episode. | Participants | NUMBER |
| SECONDARY | Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Day 28 of third subsequent malaria episode (Episode 3) | This analysis was per protocol, which includes participants who had at least 3 subsequent malaria episodes, but excludes participants if the third episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the third episode. | Participants | NUMBER |
| SECONDARY | Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Day 28 of fourth subsequent malaria episode (Episode 4) | This analysis was per protocol, which includes participants who had 4 subsequent malaria episodes, but excludes participants if the fourth episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the fourth episode. | Participants | NUMBER |
| SECONDARY | Number of Cases of Severe Malaria in Each Treatment Arm | 1 Year | The safety cohort includes all participants. | Cases of severe malaria | NUMBER |
| SECONDARY | Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants 3 Years of Age or Younger. | 1 year | The safety population includes all participants. The number of participants is limited to those who attended the final 1-year visit. | Grams/Deciliter | MEAN |
| SECONDARY | Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants Greater Than 3 Years to 5 Years of Age. | 1 year | The safety population includes all participants. The number of participants is limited to those who attended the final 1-year visit. | Grams/Deciliter | MEAN |
| SECONDARY | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 0 of initial malaria episode (Episode 0) | The safety population includes all participants who have laboratory results reported at the time point for the episode. | Micromole/Liter | MEAN |
| SECONDARY | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 14 of initial malaria episode (Episode 0) | The safety population includes all participants who have laboratory results reported at the time point for the episode. | Micromole/Liter | MEAN |
| SECONDARY | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 0 of first subsequent malaria episode (Episode 1) | The safety population includes all participants who have laboratory results reported at the time point for the episode. | Micromole/Liter | MEAN |
| SECONDARY | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 14 of first subsequent malaria episode (Episode 1) | The safety population includes all participants who have laboratory results reported at the time point for the episode. | Micromole/Liter | MEAN |
| SECONDARY | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 0 of second subsequent malaria episode (Episode 2) | The safety population includes all participants who have laboratory results reported at the time point for the episode. | Micromole/Liter | MEAN |
| SECONDARY | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 14 of second subsequent malaria episode (Episode 2) | The safety population includes all participants who have laboratory results reported at the time point for the episode. | Micromole/Liter | MEAN |
| SECONDARY | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 0 of third subsequent malaria episode (Episode 3) | The safety population includes all participants who have laboratory results reported at the time point for the episode. | Micromole/Liter | MEAN |
| SECONDARY | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 14 of third subsequent malaria episode (Episode 3) | The safety population includes all participants who have laboratory results reported at the time point for the episode. | Micromole/Liter | MEAN |
| SECONDARY | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 0 of fourth subsequent malaria episode (Episode 4) | The safety population includes all participants who have laboratory results reported at the time point for the episode. | Micromole/Liter | MEAN |
| SECONDARY | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 14 of fourth subsequent malaria episode (Episode 4) | The safety population includes all participants who have laboratory results reported at the time point for the episode. | Micromole/Liter | MEAN |
| SECONDARY | Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function) | Day 0 of initial malaria episode (Episode 0) | The safety population includes all participants who have laboratory results reported at the time point for the episode. | International Units/Liter | 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT00379821/outcomes