Trial · NCT00948896
Chemopreventive Therapy for Malaria in Ugandan Children
NCT00948896, Phase 3, Completed, University of California, San Francisco; results first posted 2015-08-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Chemopreventive Therapy for Malaria in Ugandan Children. Trials, record NCT00948896. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00948896
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemopreventive Therapy for Malaria in Ugandan Children
- NCT number
- NCT00948896
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 600 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Malaria
- Interventions
- trimethoprim-sulfamethoxazole (TS; TMP/SMX), sulfadoxine-pyrimethamine (SP), dihydroartemisinin-piperaquine (DP)
- First posted
- 2009-07-29
- Last updated
- 2015-11-24
- Results first posted
- 2015-08-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants | 6 to 24 months of age | The incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given (6-24 mo of age). Treatments within 14d of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 d after each treatment for malaria. |
| Primary | Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants | Randomization to 24 months of age | The primary outcome was the incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given. Treatments within 14 days of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 days after each treatment for malaria. |
| Secondary | Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs | Time from randomization until 24 months of age | NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events published December, 2004 |
| Secondary | Rebound Incidence of Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk | 24 months to 36 months of age |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs | Time from randomization until 24 months of age | incidence per person-year at risk | NUMBER | |
| SECONDARY | Rebound Incidence of Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk | 24 months to 36 months of age | Incidence per person year at risk | NUMBER | |
| PRIMARY | Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants | 6 to 24 months of age | Episode per person year at risk | NUMBER | |
| PRIMARY | Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants | Randomization to 24 months of age | Episodes per person year at risk | NUMBER |
Source ClinicalTrials.gov
Results by group128
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs | HIV-unexposed & no Chemoprevention | All grade 3-4 adverse events | 1.159 | incidence per person-year at risk | |
| Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs | HIV-unexposed & Monthly SP | All grade 3-4 adverse events | 1.415 | incidence per person-year at risk | |
| Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs | HIV-unexposed & Daily TS | All grade 3-4 adverse events | 0.914 | incidence per person-year at risk | |
| Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs | HIV-unexposed & Monthly DP | All grade 3-4 adverse events | 0.611 | incidence per person-year at risk | |
| Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs | HIV-exposed & no Chemoprevention | All grade 3-4 adverse events | 1.214 | incidence per person-year at risk | |
| Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs | HIV-exposed & Monthly SP | All grade 3-4 adverse events | 1.478 | incidence per person-year at risk | |
| Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs | HIV-exposed & Daily TS | All grade 3-4 adverse events | 0.659 | incidence per person-year at risk | |
| Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs | HIV-exposed & Monthly DP | All grade 3-4 adverse events | 0.678 | incidence per person-year at risk | |
| Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs | HIV-unexposed & no Chemoprevention | Grade 3-4 AEs possibly related to study drugs | NA | incidence per person-year at risk | |
| Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs | HIV-unexposed & Monthly SP | Grade 3-4 AEs possibly related to study drugs | 0.056 | incidence per person-year at risk |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization to 24 Months of Age | STARTED | HIV-unexposed & No Chemoprevention | 98 | |
| Randomization to 24 Months of Age | STARTED | HIV-unexposed & SP | 98 | |
| Randomization to 24 Months of Age | STARTED | HIV-unexposed & TS | 99 | |
| Randomization to 24 Months of Age | STARTED | HIV-unexposed & DP | 98 | |
| Randomization to 24 Months of Age | STARTED | HIV-exposed & no Chemoprevention | 46 | |
| Randomization to 24 Months of Age | STARTED | HIV-exposed & SP | 46 | |
| Randomization to 24 Months of Age | STARTED | HIV-exposed & TS | 47 | |
| Randomization to 24 Months of Age | STARTED | HIV-exposed & DP | 47 | |
| Randomization to 24 Months of Age | COMPLETED | HIV-unexposed & No Chemoprevention | 90 | |
| Randomization to 24 Months of Age | COMPLETED | HIV-unexposed & SP | 85 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events240
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | HIV-unexposed & no Chemoprevention | 31 | 98 | 39 |
| other | Anemia | Blood and lymphatic system disorders | HIV-unexposed & Monthly SP | 28 | 98 | 44 |
| other | Anemia | Blood and lymphatic system disorders | HIV-unexposed & Daily TS | 21 | 99 | 28 |
| other | Anemia | Blood and lymphatic system disorders | HIV-unexposed & Monthly DP | 17 | 98 | 19 |
| other | Anemia | Blood and lymphatic system disorders | HIV-exposed & no Chemoprevention | 14 | 46 | 18 |
| other | Anemia | Blood and lymphatic system disorders | HIV-exposed & Monthly SP | 11 | 46 | 15 |
| other | Anemia | Blood and lymphatic system disorders | HIV-exposed & Daily TS | 3 | 47 | 4 |
| other | Anemia | Blood and lymphatic system disorders | HIV-exposed & Monthly DP | 7 | 47 | 10 |
| other | Chills | Endocrine disorders | HIV-unexposed & no Chemoprevention | 0 | 98 | 0 |
| other | Chills | Endocrine disorders | HIV-unexposed & Monthly SP | 1 | 98 | 1 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HIV-unexposed & no Chemoprevention | ||
| Total, all-cause mortality | HIV-unexposed & Monthly SP | ||
| Total, all-cause mortality | HIV-unexposed & Daily TS | ||
| Total, all-cause mortality | HIV-unexposed & Monthly DP | ||
| Total, all-cause mortality | HIV-exposed & no Chemoprevention | ||
| Total, all-cause mortality | HIV-exposed & Monthly SP | ||
| Total, all-cause mortality | HIV-exposed & Daily TS | ||
| Total, all-cause mortality | HIV-exposed & Monthly DP | ||
| Total, other adverse events | HIV-unexposed & no Chemoprevention | 70 | 98 |
| Total, other adverse events | HIV-unexposed & Monthly SP | 66 | 98 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00948896
GET https://conductscience.org/api/trials/v1/NCT00948896/results?page=2