Intermittent Preventive Treatment of Malaria in Schoolchildren
IPT in Schoolchildren: Comparison of the Efficacy, Safety, and Tolerability of Antimalarial Regimens in Uganda
2 other identifiers
interventional
780
0 countries
N/A
Brief Summary
This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary objective of the study is to compare the efficacy of different combination antimalarial regimens, including amodiaquine + sulfadoxine-pyrimethamine (AQ+SP), dihydroartemisinin-piperaquine (DP), and placebo, to SP for intermittent preventive treatment (IPT) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up. This will assess both the efficacy for treatment of asymptomatic infections and the efficacy for prevention of new infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2008
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 27, 2009
CompletedResults Posted
Study results publicly available
March 21, 2024
CompletedMarch 21, 2024
March 1, 2024
4 months
February 7, 2008
September 1, 2021
March 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Risk of Parasitaemia (Unadjusted by Genotyping)
Proportion of participants whose thick blood smears that are positive for asexual parasites
after 42 days of follow-up
Secondary Outcomes (7)
Risk of Recrudescence (Adjusted by Genotyping) in Participants Who Were Parasitaemic at Enrollment
after 42 days of follow-up
Risk of New Infection (Adjusted by Genotyping) in All Participants
after 42 days of follow-up
Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment
Over 42 days of follow-up
Mean Change in Haemoglobin
Between day 0 to day 42
Risk of Serious Adverse Events
over 42 days of follow-up
- +2 more secondary outcomes
Study Arms (4)
Combination of Amodiaquine +sulfadoxine-pyrimethamine
ACTIVE COMPARATORCombination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
Dihydroartemisinin-piperaquine
ACTIVE COMPARATORDihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet)
Placebo
PLACEBO COMPARATORPlacebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya)
Sulfadoxine-pyrimethamine alone
ACTIVE COMPARATORsulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
Interventions
25 mg/kg po once on day 0
Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0
2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
Eligibility Criteria
You may qualify if:
- Age ≥ 8 to \< 14 years (boys), ≥ 8 to \< 12 years (girls)
- Student enrolled at participating school in classes 3-7
- Provision of informed consent from parent or guardian
- Provision of assent by student
You may not qualify if:
- Known allergy or history of adverse reaction to study medications
- Onset of menstruation (girls)
- Fever (≥ 37.5°C axillary) or history of fever in the previous 24 hours
- Evidence of severe malaria or danger signs
- Haemoglobin \< 7.0 gm/dL
- Parasite density \> 10,000/ul
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London School of Hygiene and Tropical Medicinelead
- Uganda Malaria Surveillance Projectcollaborator
- Ministry of Health, Ugandacollaborator
Related Publications (1)
Nankabirwa J, Cundill B, Clarke S, Kabatereine N, Rosenthal PJ, Dorsey G, Brooker S, Staedke SG. Efficacy, safety, and tolerability of three regimens for prevention of malaria: a randomized, placebo-controlled trial in Ugandan schoolchildren. PLoS One. 2010 Oct 19;5(10):e13438. doi: 10.1371/journal.pone.0013438.
PMID: 20976051DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nankabirwa Joaniter
- Organization
- Makerere University Kampala
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah G Staedke, MD
London School of Hygiene and Tropical Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 7, 2008
First Posted
February 27, 2009
Study Start
February 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
March 21, 2024
Results First Posted
March 21, 2024
Record last verified: 2024-03