Comparison of Two Strategies for the Delivery of IPTc

NCT00376155 | Completed Phase 4 DMC

• 2 other identifiers: ITCRVG47SCC990
• Study Type: interventional
• Target: 14,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

malaria; prevention; intermittent; drugs

Outcome Measures

Primary Outcomes (2)

• 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.

  during malaria transmission period

• Cost-effectiveness of the delivery system.

  during the study period

Secondary Outcomes (8)

• Coverage of IPTC

  During the study period

• the proportion of children who received three IPT courses on schedule;

  during the study period

• the proportion of children who received partial or off-schedule IPT courses

  during the study period

• the proportion of children with no IPT.

  during the study period

• Unit cost of delivery per fully adherent child.

  during the study period

Interventions

sulfadoxine /pyrimethamine plus amodiaquine DRUG

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Medical Research Council: collaborator

Study Sites (1)

MRC Laboratories

Banjul, PO Box 273, The Gambia

Location

Related Publications (1)

• 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.

  PMID: 21304921 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Sulfadoxine; Pyrimethamine; Amodiaquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kalifa Bojang, MD

  MRC Laboratories, The Gambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2006
• First Posted: September 14, 2006
• Study Start: May 1, 2006
• Study Completion: February 1, 2007
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

TH (1)