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Intermittent Preventive Treatment of Malaria in Schoolchildren

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ClinicalTrials.gov Identifier: NCT00852371
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : January 26, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Malaria Intermittent Preventive Treatment Drug: sulfadoxine-pyrimethamine Drug: amodiaquine + sulfadoxine-pyrimethamine Drug: dihydroartemisinin-piperaquine Drug: placebo Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: IPT in Schoolchildren: Comparison of the Efficacy, Safety, and Tolerability of Antimalarial Regimens in Uganda
Study Start Date : February 2008
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Risk of parasitaemia (unadjusted by genotyping) [ Time Frame: after 42 days of follow-up ]

Secondary Outcome Measures :
  1. Risk of recrudescence (adjusted by genotyping) in children who were parasitaemic at enrollment [ Time Frame: after 42 days of follow-up ]
  2. Risk of new infection (adjusted by genotyping) in all children [ Time Frame: after 42 days of follow-up ]
  3. 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 ]
  4. 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 ]
  5. Mean haemoglobin [ Time Frame: at day 42 ]
  6. Mean change in haemoglobin [ Time Frame: between day 0 to day 42 ]
  7. Risk of serious adverse events [ Time Frame: over 42 days of follow-up ]
  8. Risk of all adverse events [ Time Frame: after 14 and 42 days of follow-up ]
  9. Acceptability of IPT regimens [ Time Frame: on day 7 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852371

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00852371     History of Changes
Other Study ID Numbers: ITCRVG49
LSHTM Ethics 5197
First Posted: February 27, 2009    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017

Keywords provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:
Intermittent preventive treatment

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Fanasil, pyrimethamine drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents