Trial · NCT00513500
Zambia Integrated Management of Malaria and Pneumonia Study
NCT00513500, Not applicable, Completed, Boston University; results first posted 2010-07-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Zambia Integrated Management of Malaria and Pneumonia Study. Trials, record NCT00513500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00513500
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Zambia Integrated Management of Malaria and Pneumonia Study
- NCT number
- NCT00513500
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 3,125 participants, actual
- Lead sponsor
- Boston University
- Conditions
- Pneumonia, Malaria
- Interventions
- Coartem and amoxicillin, Coartem
- First posted
- 2007-08-08
- Last updated
- 2010-07-20
- Results first posted
- 2010-07-13
- Limitations and caveats
- Imbalance in enrollment. More patients enrolled in the control arm possibly due to many control community health workers working full time and available to see patients all day.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Children Who Received Early and Appropriate Treatment for Pneumonia. | one year | Early and appropriate is defined as receiving 13-15 doses of amoxicillin over 5 days and receiving the first dose within 24-48 hours of onset of first symptom |
| Primary | Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) | one year | |
| Secondary | Number of Children Who do Not Respond to Treatment for Pneumonia | one year |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Children Who Received Early and Appropriate Treatment for Pneumonia. | one year | The number of participants determined for this analysis was based on those classified as pneumonia. The analysis was based on an intent-to-treat basis. | partcipants | NUMBER |
| PRIMARY | Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) | one year | The participants analyzed was based on children reported with fever. Analysis was per intention to treat. | participants | NUMBER |
| SECONDARY | Number of Children Who do Not Respond to Treatment for Pneumonia | one year | Based on number classified as having pneumonia. Analysis was per intention to treat | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Children Who Received Early and Appropriate Treatment for Pneumonia. | Enhanced Treatment | 247 | partcipants | ||
| Number of Children Who Received Early and Appropriate Treatment for Pneumonia. | Current Practice | 27 | partcipants | ||
| Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) | Enhanced Treatment | 265 | participants | ||
| Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) | Current Practice | 2066 | participants | ||
| Number of Children Who do Not Respond to Treatment for Pneumonia | Enhanced Treatment | 41 | participants | ||
| Number of Children Who do Not Respond to Treatment for Pneumonia | Current Practice | 41 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Enhanced Treatment | 1,017 | |
| Overall Study | STARTED | Current Practice | 2,108 | |
| Overall Study | COMPLETED | Enhanced Treatment | 976 | |
| Overall Study | COMPLETED | Current Practice | 2,054 | |
| Overall Study | NOT COMPLETED | Enhanced Treatment | 41 | |
| Overall Study | NOT COMPLETED | Current Practice | 54 |
Source ClinicalTrials.gov
Adverse events6
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 | RDT related | Skin and subcutaneous tissue disorders | Enhanced Treatment | 16 | 973 | 16 |
| other | RDT related | Skin and subcutaneous tissue disorders | Current Practice | 0 | 2,018 | 0 |
| serious | Deaths | Infections and infestations | Enhanced Treatment | 2 | 1,017 | 1,017 |
| serious | Deaths | Infections and infestations | Current Practice | 1 | 2,108 | 2,108 |
| serious | Hospitalization | Infections and infestations | Enhanced Treatment | 4 | 1,017 | 1,017 |
| serious | Hospitalization | Infections and infestations | Current Practice | 14 | 2,108 | 2,108 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enhanced Treatment | ||
| Total, all-cause mortality | Current Practice | ||
| Total, other adverse events | Enhanced Treatment | 16 | 973 |
| Total, other adverse events | Current Practice | 0 | 2,018 |
| Total, serious adverse events | Enhanced Treatment | 6 | 1,017 |
| Total, serious adverse events | Current Practice | 15 | 2,108 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20877714 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Enhanced Treatment vs Current Practice: Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) | Trial comparisons |
| Enhanced Treatment vs Current Practice: Number of Children Who do Not Respond to Treatment for Pneumonia | Trial comparisons |
| Enhanced Treatment vs Current Practice: serious adverse events | Trial comparisons |
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/NCT00513500
GET https://conductscience.org/api/trials/v1/NCT00513500/registered