MedTrace Logo

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

NCT00944840 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1312

Last updated 2017-01-26

No results posted yet for this study

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

Interventions

DRUG

SP plus amodiaquine

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

DRUG

SP placebo plus amodiaquine placebo

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

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Kalifa Bojang, MD, PhD · MRC Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-07-31
Completion
2009-08-31

Countries

  • The Gambia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00944840 on ClinicalTrials.gov