Intermittent Preventive Treatment of Malaria in Schoolchildren - Full Text View

Sponsors and Collaborators:	Gates Malaria Partnership 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

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	IPT in Schoolchildren: Comparison of the Efficacy, Safety, and Tolerability of Antimalarial Regimens in Uganda

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Pyrimethamine Fansidar Dihydroquinghaosu Amodiaquine Sulfadoxine Piperaquine Amodiaquine hydrochloride

U.S. FDA Resources

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
2: Active Comparator 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
3: Active Comparator Dihydroartemisinin-piperaquine	Drug: dihydroartemisinin-piperaquine 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
4: Placebo Comparator Placebo	Drug: placebo dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
1: Active Comparator sulfadoxine-pyrimethamine	Drug: sulfadoxine-pyrimethamine 25 mg/kg po once on day 0

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

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

Responsible Party:	London School of Hygiene and Tropical Medicine ( Amit Bhasin )
Study ID Numbers:	ITCRVG49, LSHTM Ethics 5197
Study First Received:	February 7, 2008
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00852371 History of Changes
Health Authority:	Uganda: National Council for Science and Technology

Keywords provided by Gates Malaria Partnership:

Malaria
Intermittent preventive treatment
Efficacy
Safety

Tolerability
Schoolchildren
Uganda

Study placed in the following topic categories:

Pyrimethamine
Protozoan Infections
Anti-Infective Agents
Sulfadoxine-pyrimethamine
Amodiaquine
Folate
Anti-Infective Agents, Urinary
Malaria
Folinic Acid

Sulfadoxine
Folic Acid Antagonists
Vitamin B9
Folic Acid
Piperaquine
Antimalarials
Parasitic Diseases
Dihydroquinghaosu

Additional relevant MeSH terms:

Pyrimethamine
Anti-Infective Agents
Protozoan Infections
Amodiaquine
Sulfadoxine-pyrimethamine
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Coccidiosis
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Malaria

Renal Agents
Folic Acid Antagonists
Sulfadoxine
Pharmacologic Actions
Piperaquine
Antimalarials
Antiparasitic Agents
Therapeutic Uses
Parasitic Diseases
Dihydroquinghaosu

ClinicalTrials.gov processed this record on September 04, 2009