Trial · NCT00852371

Intermittent Preventive Treatment of Malaria in Schoolchildren

NCT00852371, Phase 3, Completed, London School of Hygiene and Tropical Medicine; results first posted 2024-03-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Intermittent Preventive Treatment of Malaria in Schoolchildren. Trials, record NCT00852371. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00852371

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Intermittent Preventive Treatment of Malaria in Schoolchildren
NCT number: NCT00852371
Status: Completed
Phases: Phase 3
Enrollment: 780 participants, actual
Lead sponsor: London School of Hygiene and Tropical Medicine
Conditions: Malaria, Intermittent Preventive Treatment
Interventions: sulfadoxine-pyrimethamine, amodiaquine + sulfadoxine-pyrimethamine, dihydroartemisinin-piperaquine, Placebo
First posted: 2009-02-27
Last updated: 2024-03-21
Results first posted: 2024-03-21

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Risk of Parasitaemia (Unadjusted by Genotyping)	after 42 days of follow-up	Proportion of participants whose thick blood smears that are positive for asexual parasites
Secondary	Risk of Recrudescence (Adjusted by Genotyping) in Participants Who Were Parasitaemic at Enrollment	after 42 days of follow-up	Proportion of participants whose thick blood smears that are positive with the same asexual parasites at baseline and on the day of failure at genotyping
Secondary	Risk of New Infection (Adjusted by Genotyping) in All Participants	after 42 days of follow-up	Proportion of participants whose thick blood smears that are positive for new asexual parasites on day of failure at genotyping
Secondary	Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment	Over 42 days of follow-up	Proportion of children who were parasitaemia at enrollment, with subsequent fever and a positive thick blood smear for asexual parasites on the day of failure during follow-up
Secondary	Mean Change in Haemoglobin	Between day 0 to day 42	Haemoglobin measured in g/dL; Mean change in haemoglobin calculated as the difference in mean haemoglobin (g/dL) on Day 42 - Day 0, in children treated with the different antimalarial regimens
Secondary	Risk of Serious Adverse Events	over 42 days of follow-up	Any untoward medical occurrence in a participant taking study medication after 14 and 42 days of follow up leading to death, disability, hospitalization or extended hospitalization
Secondary	Acceptability of IPT Regimens	on day 7	Perceived willingness to take study medication as routine preventive treatment
Secondary	Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment	after 42 days of follow-up	Proportion of children who were parasitaemia at enrollment, with subsequent fever and a positive thick blood smear for asexual parasites on the day of failure during follow-up

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Risk of Parasitaemia (Unadjusted by Genotyping)	after 42 days of follow-up		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Risk of Recrudescence (Adjusted by Genotyping) in Participants Who Were Parasitaemic at Enrollment	after 42 days of follow-up		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Risk of New Infection (Adjusted by Genotyping) in All Participants	after 42 days of follow-up		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment	Over 42 days of follow-up		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean Change in Haemoglobin	Between day 0 to day 42		g/dL	MEAN
SECONDARY	Risk of Serious Adverse Events	over 42 days of follow-up		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Acceptability of IPT Regimens	on day 7		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment	after 42 days of follow-up	Risk of recrudescence in children with parasites on day 0 (n=392). The risk of recrudescence was estimated using Kaplan-Meier survival techniques with corresponding 95% confidence intervals (CI) calculated using Greenwood variance estimates.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Risk of Parasitaemia (Unadjusted by Genotyping)	Dihydroartemisinin-piperaquine	23	Participants
Risk of Parasitaemia (Unadjusted by Genotyping)	Combination of Amodiaquine +Sulfadoxine-pyrimethamine	87	Participants
Risk of Parasitaemia (Unadjusted by Genotyping)	Placebo	164	Participants
Risk of Parasitaemia (Unadjusted by Genotyping)	Sulfadoxine-pyrimethamine Alone	147	Participants
Risk of Recrudescence (Adjusted by Genotyping) in Participants Who Were Parasitaemic at Enrollment	Dihydroartemisinin-piperaquine	2	Participants
Risk of Recrudescence (Adjusted by Genotyping) in Participants Who Were Parasitaemic at Enrollment	Combination of Amodiaquine +Sulfadoxine-pyrimethamine	6	Participants
Risk of Recrudescence (Adjusted by Genotyping) in Participants Who Were Parasitaemic at Enrollment	Placebo	64	Participants
Risk of Recrudescence (Adjusted by Genotyping) in Participants Who Were Parasitaemic at Enrollment	Sulfadoxine-pyrimethamine Alone	50	Participants
Risk of New Infection (Adjusted by Genotyping) in All Participants	Dihydroartemisinin-piperaquine	12	Participants
Risk of New Infection (Adjusted by Genotyping) in All Participants	Combination of Amodiaquine +Sulfadoxine-pyrimethamine	55	Participants

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dihydroartemisinin-piperaquine	198
Overall Study	STARTED	Combination of Amodiaquine +Sulfadoxine-pyrimethamine	200
Overall Study	STARTED	Placebo	196
Overall Study	STARTED	Sulfadoxine-pyrimethamine Alone	186
Overall Study	COMPLETED	Dihydroartemisinin-piperaquine	196
Overall Study	COMPLETED	Combination of Amodiaquine +Sulfadoxine-pyrimethamine	197
Overall Study	COMPLETED	Placebo	192
Overall Study	COMPLETED	Sulfadoxine-pyrimethamine Alone	184
Overall Study	NOT COMPLETED	Dihydroartemisinin-piperaquine	2
Overall Study	NOT COMPLETED	Combination of Amodiaquine +Sulfadoxine-pyrimethamine	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events16

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	Fever	Infections and infestations	Dihydroartemisinin-piperaquine	6	198	6
other	Fever	Infections and infestations	Combination of Amodiaquine +Sulfadoxine-pyrimethamine	7	200	7
other	Fever	Infections and infestations	Placebo	16	196	16
other	Fever	Infections and infestations	Sulfadoxine-pyrimethamine Alone	10	186	10
other	Headache	Infections and infestations	Dihydroartemisinin-piperaquine	49	198	49
other	Headache	Infections and infestations	Combination of Amodiaquine +Sulfadoxine-pyrimethamine	53	200	53
other	Headache	Infections and infestations	Placebo	50	196	50
other	Headache	Infections and infestations	Sulfadoxine-pyrimethamine Alone	40	186	40
other	Cough	Respiratory, thoracic and mediastinal disorders	Dihydroartemisinin-piperaquine	54	198	54
other	Cough	Respiratory, thoracic and mediastinal disorders	Combination of Amodiaquine +Sulfadoxine-pyrimethamine	35	200	35

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dihydroartemisinin-piperaquine	0	198
Total, all-cause mortality	Combination of Amodiaquine +Sulfadoxine-pyrimethamine	0	200
Total, all-cause mortality	Placebo	0	196
Total, all-cause mortality	Sulfadoxine-pyrimethamine Alone	0	186
Total, other adverse events	Dihydroartemisinin-piperaquine	117	198
Total, other adverse events	Combination of Amodiaquine +Sulfadoxine-pyrimethamine	122	200
Total, other adverse events	Placebo	124	196
Total, other adverse events	Sulfadoxine-pyrimethamine Alone	114	186
Total, serious adverse events	Dihydroartemisinin-piperaquine	0	198
Total, serious adverse events	Combination of Amodiaquine +Sulfadoxine-pyrimethamine	0	200

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20976051	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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00852371

GET https://conductscience.org/api/trials/v1/NCT00852371/results?page=2

API reference For AI assistants