Trial · NCT00379821
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Clinical Malaria Episodes Per Year of Follow-up | 1 year | Clinical malaria episode was defined as at least one symptom of malaria and a positive malaria smear. The number of clinical malaria episodes (not including the initial malaria episode) reported by participants during follow up is presented as the number per Person Years at Risk (PYAR). |
| Secondary | Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Day 28 of initial malaria episode (Episode 0) | Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure. |
| 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) | Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure. |
| 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) | Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure. |
| 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) | Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure. |
| 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) | Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure. |
| Secondary | Number of Cases of Severe Malaria in Each Treatment Arm | 1 Year | A case of severe malaria included one or more of the following: Hemoglobin ≤5 g/dL; prostration; respiratory distress; bleeding; recent seizures, coma or obtundation (Blantyre coma score \< 5); inability to drink, or persistent vomiting. All cases were then adjudicated by a panel of investigators prior to analysis. |
| 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 | Hemoglobin values were assessed from blood collected at the last study visit at one year after enrollment. Group means are stratified by participants 3 years of age and under, and over 3 to 5 years of age. |
| 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 | Hemoglobin values were assessed from blood collected at the last study visit at one year after enrollment. Group means are stratified by participants 3 years of age and under, and over 3 to 5 years of age. |
| Secondary | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 0 of initial malaria episode (Episode 0) | Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection. |
| Secondary | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 14 of initial malaria episode (Episode 0) | Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection. |
| Secondary | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 0 of first subsequent malaria episode (Episode 1) | Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection. |
| Secondary | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 14 of first subsequent malaria episode (Episode 1) | Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection. |
| Secondary | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 0 of second subsequent malaria episode (Episode 2) | Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection. |
| Secondary | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 14 of second subsequent malaria episode (Episode 2) | Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection. |
| Secondary | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 0 of third subsequent malaria episode (Episode 3) | Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection. |
| Secondary | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 14 of third subsequent malaria episode (Episode 3) | Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection. |
| Secondary | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 0 of fourth subsequent malaria episode (Episode 4) | Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection. |
| Secondary | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 14 of fourth subsequent malaria episode (Episode 4) | Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection. |
| Secondary | Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function) | Day 0 of initial malaria episode (Episode 0) | ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. |
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/registered