Intermittent Preventive Treatment of Malaria in Schoolchildren

This study has been completed.
Sponsor:
Collaborators:
Uganda Malaria Surveillance Project
London School of Hygiene and Tropical Medicine
Ministry of Health, Uganda
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00852371
First received: February 7, 2008
Last updated: February 26, 2009
Last verified: February 2009
  Purpose

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
Malaria
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
Dihydroartemisinin-piperaquine
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
Placebo
Drug: placebo
dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
Active Comparator: 1
sulfadoxine-pyrimethamine
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.

  Eligibility

Ages Eligible for Study:   8 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00852371

Sponsors and Collaborators
Gates Malaria Partnership
Uganda Malaria Surveillance Project
London School of Hygiene and Tropical Medicine
Ministry of Health, Uganda
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amit Bhasin, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov 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:
Malaria
Intermittent preventive treatment
Efficacy
Safety
Tolerability
Schoolchildren
Uganda

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Amodiaquine
Pyrimethamine
Sulfadoxine
Dihydroquinghaosu
Artemisinins
Sulfadoxine-pyrimethamine
Piperaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on July 20, 2014