Comparison of Two Strategies for the Delivery of IPTc

Study Description

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Brief Summary:

Antimalarial chemoprophylaxis can reduce morbidity and mortality from malaria in children. However, this approach to malaria control has not been implemented widely because of concerns over its possible effect on the development of resistance and natural immunity. Intermittent preventive treatment (IPT) may be able to achieve some of the beneficial effects of chemoprophylaxis without its drawbacks. Recently, it has been shown that IPT given to Senegalese children under the age of five years on three occasions during the malaria transmission season reduced the incidence of clinical malaria by approximately 90%. However, it is uncertain how this intervention can be most effectively delivered. Therefore, 26 Maternal and Child Health (MCH) trekking clinics in Upper River Division, south of the River Gambia, each with an average catchment population of 400-500 children under 5 years of age, will be randomly allocated to receive IPT from the MCH trekking team or from a IPT dispenser (village health worker, traditional birth attendant or a community mother based in a primary health care village). Treatment with a single dose of sulfadoxine /pyrimethamine (SP) plus three doses of amodiaquine will be given to all study subjects at monthly intervals on three occasions during the months of September, October and November. The primary end points will be the incidence of clinical attacks of malaria detected by passive case detection, and cost-effectiveness of the delivery methods. Important secondary endpoints will be the coverage and the equity of coverage of IPT in preventing malaria morbidity.

Condition or disease	Intervention/treatment	Phase
Malaria	Drug: sulfadoxine /pyrimethamine plus amodiaquine	Phase 4

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	14000 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Comparison of Two Strategies for the Delivery of Intermittent Preventive Treatment in Children (IPTc) in an Area of Seasonal Malaria Transmission
Study Start Date :	May 2006
Actual Study Completion Date :	February 2007

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Malaria incidence (the number of OPD attendances with clinical malaria that meet the case definitions as indicated below during the surveillance period ) and the number of hospital admissions with malaria during the surveillance period. [ Time Frame: during malaria transmission period ]
2. Cost-effectiveness of the delivery system. [ Time Frame: during the study period ]

Secondary Outcome Measures :

1. Coverage of IPTC [ Time Frame: During the study period ]
2. the proportion of children who received three IPT courses on schedule; [ Time Frame: during the study period ]
3. the proportion of children who received partial or off-schedule IPT courses [ Time Frame: during the study period ]
4. the proportion of children with no IPT. [ Time Frame: during the study period ]
5. Unit cost of delivery per fully adherent child. [ Time Frame: during the study period ]
6. Incremental cost-effectiveness ratio for each systems of delivery. [ Time Frame: During the study period ]
7. Mean Hb (g/dl) [ Time Frame: at the end of malaria transmission ]
8. Prevalence of malaria parasitaemia [ Time Frame: At the end of the malaria transmission season ]

Eligibility Criteria

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Ages Eligible for Study:	3 Months to 5 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

1. Age between 3 months and 5 years at enrolment.
2. Informed consent obtained from parents or legal guardians.
3. No current participation in another malaria intervention trial.

Exclusion Criteria:

1. Previous adverse reaction to treatment with SP or amodiaquine. If this is unknown, then a history of allergic reaction to any drug.

Contacts and Locations

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Locations

Gambia
MRC Laboratories
Banjul, Gambia, PO Box 273

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine

Medical Research Council

Investigators

Principal Investigator:	Kalifa Bojang, MD	MRC Laboratories, The Gambia

More Information

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Additional Information:

Gates Malaria Partnership 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bojang KA, Akor F, Conteh L, Webb E, Bittaye O, Conway DJ, Jasseh M, Wiseman V, Milligan PJ, Greenwood B. Two strategies for the delivery of IPTc in an area of seasonal malaria transmission in the Gambia: a randomised controlled trial. PLoS Med. 2011 Feb 1;8(2):e1000409. doi: 10.1371/journal.pmed.1000409.

Responsible Party:	Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:	NCT00376155 History of Changes
Other Study ID Numbers:	ITCRVG47; SCC990
First Posted:	September 14, 2006
Last Update Posted:	February 10, 2017
Last Verified:	February 2017

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

malaria; prevention; intermittent; drugs

Additional relevant MeSH terms:

Malaria; Protozoan Infections; Parasitic Diseases; Pyrimethamine; Sulfadoxine; Amodiaquine; Antimalarials; Antiprotozoal Agents	Antiparasitic Agents; Anti-Infective Agents; Folic Acid Antagonists; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Urinary; Renal Agents