Intermittent Preventive Treatment of Malaria in Schoolchildren

This study has been completed.
Uganda Malaria Surveillance Project
London School of Hygiene and Tropical Medicine
Ministry of Health, Uganda
Information provided by:
Gates Malaria Partnership Identifier:
First received: February 7, 2008
Last updated: February 26, 2009
Last verified: February 2009
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.

Condition Intervention Phase
Intermittent Preventive Treatment
Drug: sulfadoxine-pyrimethamine
Drug: amodiaquine + sulfadoxine-pyrimethamine
Drug: dihydroartemisinin-piperaquine
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: IPT in Schoolchildren: Comparison of the Efficacy, Safety, and Tolerability of Antimalarial Regimens in Uganda

Resource links provided by NLM:

Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • Risk of parasitaemia (unadjusted by genotyping) [ Time Frame: after 42 days of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Risk of recrudescence (adjusted by genotyping) in children who were parasitaemic at enrollment [ Time Frame: after 42 days of follow-up ] [ Designated as safety issue: No ]
  • Risk of new infection (adjusted by genotyping) in all children [ Time Frame: after 42 days of follow-up ] [ Designated as safety issue: No ]
  • Risk of clinical failure due to recrudescence (adjusted by genotyping) in children who were parasitaemic at enrollment [ Time Frame: after 42 days of follow-up ] [ Designated as safety issue: No ]
  • Risk of parasitological failure due to recrudescence (adjusted by genotyping) in children who were parasitaemic at enrollment [ Time Frame: after 42 days of follow-up ] [ Designated as safety issue: No ]
  • Mean haemoglobin [ Time Frame: at day 42 ] [ Designated as safety issue: No ]
  • Mean change in haemoglobin [ Time Frame: between day 0 to day 42 ] [ Designated as safety issue: No ]
  • Risk of serious adverse events [ Time Frame: over 42 days of follow-up ] [ Designated as safety issue: Yes ]
  • Risk of all adverse events [ Time Frame: after 14 and 42 days of follow-up ] [ Designated as safety issue: Yes ]
  • Acceptability of IPT regimens [ Time Frame: on day 7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 760
Study Start Date: February 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Amodiaquine + sulfadoxine-pyrimethamine
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
Other Names:
  • Camoquin, Pfizer
  • Fansidar, Roche
Active Comparator: 3
Drug: dihydroartemisinin-piperaquine
2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
Other Name: Duocotexcin, Holley Cotec Pharmaceuticals
Placebo Comparator: 4
Drug: placebo
dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
Active Comparator: 1
Drug: sulfadoxine-pyrimethamine
25 mg/kg po once on day 0
Other Name: Fansidar, Roche

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.

Ages Eligible for Study:   8 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00852371

Sponsors and Collaborators
Gates Malaria Partnership
Uganda Malaria Surveillance Project
London School of Hygiene and Tropical Medicine
Ministry of Health, Uganda
Principal Investigator: Sarah G Staedke, MD London School of Hygiene and Tropical Medicine
  More Information

No publications provided by Gates Malaria Partnership

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Amit Bhasin, London School of Hygiene and Tropical Medicine Identifier: NCT00852371     History of Changes
Other Study ID Numbers: ITCRVG49  LSHTM Ethics 5197 
Study First Received: February 7, 2008
Last Updated: February 26, 2009
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Gates Malaria Partnership:
Intermittent preventive treatment

Additional relevant MeSH terms:
Parasitic Diseases
Protozoan Infections
Fanasil, pyrimethamine drug combination
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses processed this record on February 11, 2016