Intermittent Preventive Treatment (IPTc) and Home Based Management of Malaria (HMM)in The Gambia

NCT00944840 | Completed Phase 3

• 1 other identifier: SCC 1124
• Study Type: interventional
• Target: 1,312
• Locations: 1 country
• Sites: 1

Brief Summary

Malaria in African countries remains an important cause of mortality and morbidity among young children. The global malaria control strategies include prompt treatment with an effective antimalarial drug, vector control using ITNs or curtains, indoor residual spraying (IRS), and intermittent preventive treatment. However, individually these interventions provide only imperfect protection. Thus, there is a need to investigate whether additional control measures provide added benefit in reducing mortality and morbidity. Therefore, 1312 children under 5 years of age living in villages and hamlets near Farafenni, The Gambia, which form part of the rural Farafenni Demographic Surveillance system (FDSS) in North Bank Region(NBR) were randomly allocated to receive IPTc or placebo from village health workers based in primary health care villages. Treatment with a single dose of sulfadoxine /pyrimethamine plus three doses of amodiaquine or placebo was given to all study subjects at monthly intervals on three occasions during the months of September, October and November. In addition, VHWs were trained to administer treatment with coartem to children if they develop symptoms compatible with malaria during the malaria transmission season. The primary end point was the incidence of clinical attacks of malaria detected during the study.

Conditions

Malaria

Keywords

Intermittent Preventive Treatment; Home based management of malaria

Outcome Measures

Primary Outcomes (1)

• Malaria incidence (the number of study subjects seen at the OPD clinic with clinical malaria during the surveillance period).

  During the surveillance period (September to December 2008)

Secondary Outcomes (1)

• prevalence of parasitaemia at the end of malaria transmission season in December 2008

  December 2008

Study Arms (2)

SP and amodiaquine

ACTIVE COMPARATOR

Study subjects received intermittent preventive treatment with SP plus amodiaquine.

Drug: SP plus amodiaquine

SP placebo plus amodiaquine placebo

PLACEBO COMPARATOR

Intermittent preventive treatment with SP placebo and amodiaquine placebo

Drug: SP placebo plus amodiaquine placebo

Interventions

SP plus amodiaquine DRUG

SP plus amodiaquine or placebo at monthly interval during September, October and November

Also known as: Camoquin, Fansidar

SP and amodiaquine

SP placebo plus amodiaquine placebo DRUG

monthly treatment with amodiaquine and SP or placebo during September, October and November

SP placebo plus amodiaquine placebo

Eligibility Criteria

• Age: 3 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age between 3 months and 59 months at enrolment.
• Informed consent obtained from parents or legal guardians.
• No current participation in another malaria intervention trial
• Permanent residence in the study area with no intention of leaving during the surveillance period.

You may not qualify if:

• Previous adverse reaction to treatment with SP, amodiaquine or Coartem. If this is unknown, then a history of allergic reaction to any drug.
• Temporary residence in the study area
• Lack of informed consent
• Presence of a severe, chronic illness such as severe malnutrition or AIDS, likely to interfere with evaluation of the trial results.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead

Study Sites (1)

Farafenni Field Station, MRC Laboratories

Farafenni, North Bank Division, The Gambia

Location

Related Publications (1)

• Sesay S, Milligan P, Touray E, Sowe M, Webb EL, Greenwood BM, Bojang KA. A trial of intermittent preventive treatment and home-based management of malaria in a rural area of The Gambia. Malar J. 2011 Jan 7;10:2. doi: 10.1186/1475-2875-10-2.

  PMID: 21214940 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Amodiaquine; fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kalifa Bojang, MD, PhD

  MRC Laboratories

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 23, 2009
• Study Start: September 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

TH (1)