Comparison of Two Strategies for the Delivery of IPTc

This study has been completed.
Sponsor:
Collaborator:
Medical Research Council
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00376155
First received: September 13, 2006
Last updated: February 7, 2008
Last verified: February 2008
  Purpose

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 Intervention Phase
Malaria
Drug: sulfadoxine /pyrimethamine plus amodiaquine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • 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 ]
  • Cost-effectiveness of the delivery system. [ Time Frame: during the study period ]

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

Enrollment: 14000
Study Start Date: May 2006
Study Completion Date: February 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Months to 5 Years
Genders Eligible for Study:   Both
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
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: NCT00376155

Locations
Gambia
MRC Laboratories
Banjul, Gambia, PO Box 273
Sponsors and Collaborators
Gates Malaria Partnership
Medical Research Council
Investigators
Principal Investigator: Kalifa Bojang, MD MRC Laboratories, The Gambia
  More Information

No publications provided by Gates Malaria Partnership

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00376155     History of Changes
Other Study ID Numbers: ITCRVG47, SCC990
Study First Received: September 13, 2006
Last Updated: February 7, 2008
Health Authority: Gambia: MRC Ethics Committee

Keywords provided by Gates Malaria Partnership:
malaria
prevention
intermittent
drugs

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014