Intermittent Preventive Treatment of Malaria in Schoolchildren

NCT ID: NCT00852371

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 780 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2008-06-30

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.

Detailed Description

The study will be carried out among children aged ≥ 8 to < 14 years (boys) and ≥ 8 to < 12 years (girls) attending primary schools in Tororo district. Schools will be selected using convenience sampling with the assistance of the district and the education sector. The target population includes children attending primary schools in Uganda. The accessible population includes the children attending the participating primary schools in classes 3-7 in Tororo district. Children who meet the selection criteria for participation in the study will be randomized to treatment with one of the four study regimens and will be followed for 42 days. Repeat evaluations will be performed on days 1, 2, 3, 7, 14, 28, and 42 (and any unscheduled day that a student is ill) and will include assessment for the occurrence of adverse events. Treatment efficacy outcomes will be assessed using revised WHO outcome classification criteria. Acceptability of treatment regimens will be assessed using a questionnaire administered to participating students on day 7. The primary outcome measure is risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up.

Conditions

Malaria; Intermittent Preventive Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Combination of Amodiaquine +sulfadoxine-pyrimethamine

Combination 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

Group Type: ACTIVE_COMPARATOR

amodiaquine + sulfadoxine-pyrimethamine

Intervention Type: DRUG

Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0

Dihydroartemisinin-piperaquine

Dihydroartemisinin-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)

Group Type: ACTIVE_COMPARATOR

dihydroartemisinin-piperaquine

Intervention Type: DRUG

2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)

Placebo

Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

dosed as for amodiaquine (10mg/kg po daily on days 1, 2)

Sulfadoxine-pyrimethamine alone

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

Group Type: ACTIVE_COMPARATOR

sulfadoxine-pyrimethamine

Intervention Type: DRUG

25 mg/kg po once on day 0

Interventions

sulfadoxine-pyrimethamine

25 mg/kg po once on day 0

Intervention Type: DRUG

amodiaquine + sulfadoxine-pyrimethamine

Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0

Intervention Type: DRUG

dihydroartemisinin-piperaquine

2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)

Intervention Type: DRUG

Placebo

dosed as for amodiaquine (10mg/kg po daily on days 1, 2)

Intervention Type: OTHER

Other Intervention Names

Fansidar, Roche; Camoquin, Pfizer; Fansidar, Roche; Duocotexcin, Holley Cotec Pharmaceuticals; No active ingredient

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uganda Malaria Surveillance Project

OTHER

Sponsor Role: collaborator

Ministry of Health, Uganda

OTHER_GOV

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Brian Greenwood

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah G Staedke, MD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

References

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.

Reference Type: DERIVED

PMID: 20976051 (View on PubMed)

Other Identifiers

LSHTM Ethics 5197

Identifier Type: OTHER

Identifier Source: secondary_id

ITCRVG49

Identifier Type: -

Identifier Source: org_study_id