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

This study has been completed.
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00944840
First received: July 22, 2009
Last updated: July 1, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Malaria
Drug: SP plus amodiaquine
Drug: SP placebo plus amodiaquine placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Trial of Intermittent Preventive Treatment and Home Based Management of Malaria in a Rural Area of The Gambia

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • Malaria incidence (the number of study subjects seen at the OPD clinic with clinical malaria during the surveillance period). [ Time Frame: During the surveillance period (September to December 2008) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • prevalence of parasitaemia at the end of malaria transmission season in December 2008 [ Time Frame: December 2008 ] [ Designated as safety issue: No ]

Enrollment: 1312
Study Start Date: September 2008
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SP and amodiaquine
Study subjects received intermittent preventive treatment with SP plus amodiaquine.
Drug: SP plus amodiaquine
SP plus amodiaquine or placebo at monthly interval during September, October and November
Other Names:
  • Camoquin
  • Fansidar
Placebo Comparator: SP placebo plus amodiaquine placebo
Intermittent preventive treatment with SP placebo and amodiaquine placebo
Drug: SP placebo plus amodiaquine placebo
monthly treatment with amodiaquine and SP or placebo during September, October and November

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Previous adverse reaction to treatment with SP, amodiaquine or Coartem. If this is unknown, then a history of allergic reaction to any drug.
  2. Temporary residence in the study area
  3. Lack of informed consent
  4. Presence of a severe, chronic illness such as severe malnutrition or AIDS, likely to interfere with evaluation of the trial results.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944840

Locations
Gambia
Farafenni Field Station, MRC Laboratories
Farafenni, North Bank Region, Gambia
Sponsors and Collaborators
Gates Malaria Partnership
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Kalifa Bojang, MD, PhD MRC Laboratories
  More Information

No publications provided by Gates Malaria Partnership

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Kalifa Bojang, MRC Laboratories, The Gambia
ClinicalTrials.gov Identifier: NCT00944840     History of Changes
Other Study ID Numbers: SCC 1124
Study First Received: July 22, 2009
Last Updated: July 1, 2010
Health Authority: Gambia: MRC Ethics Committee

Keywords provided by Gates Malaria Partnership:
Intermittent Preventive Treatment
Home based management of malaria

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Amodiaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014