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Zambia Integrated Management of Malaria and Pneumonia Study (ZIMMAPS)
This study is not yet open for participant recruitment.
Study NCT00513500   Information provided by Boston University
First Received: August 7, 2007   Last Updated: August 8, 2007   History of Changes

August 7, 2007
August 8, 2007
September 2007
 
  • Measure proportion of children who receive early and appropriate treatment for pneumonia [ Time Frame: one year ]
  • Determine the extent to which the use of RDTs by CHWs reduces the use of Coartem in managing children with acute fever [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT00513500 on ClinicalTrials.gov Archive Site
  • Measure proportion of children who do not respond to treatment [ Time Frame: one year ]
  • Measure the cost-effectiveness of CHWs managing malaria using Coartem with RDTs [ Time Frame: one year ]
  • Measure proportion of children wdo do not respond to treatment [ Time Frame: one year ]
  • Measure the cost-effectiveness of CHWs managing malaria using Coartem with RDTs [ Time Frame: one year ]
 
Zambia Integrated Management of Malaria and Pneumonia Study
Zambia Integrated Management of Malaria and Pneumonia Study

The purpose of the study is to demonstrate the effectiveness and feasibility of community-based management of pneumonia and malaria by community health workers (CHWs) in a rural district of Zambia.

Pneumonia and malaria are the two leading causes of morbidity and mortality among children under five in sub-Saharan Africa. Due to limited access to health services in many developing countries, a number of global health organizations, including the World Health Organization, have strongly advocated the use of community health workers (CHWs) to deliver basic health care in the community and to facilitate referral to primary health facilities.

Existing supported CHWs in the study area will be trained in the assessment and classification of children between six months and five years of age presenting with fever and/or cough/difficult breathing. In the intervention arm, CHWs will be supplied with rapid diagnostic tests (RDTs), Coartem (a fixed dose combination of artemether-lumefantrine) and amoxicillin. The intervention CHWs will be trained to use RDTs in patients with reported fever and provide those with a positive result with Coartem; and patients suspected of pneumonia (based on fast breathing) will be treated with amoxicillin as per the standard of care at health facilities and monitored. In the control arm, no RDT will be performed. The CHWs will be supplied with Coartem to treat malaria/febrile illness as per the integrated management of childhood illnesses (IMCI) guidelines and patients suspected of pneumonia will be referred to the health facility for treatment as per the current practice. Data collectors will routinely visit CHWs to collect data on their consultations and follow-up patients treated by CHWs in their homes..

 
Interventional
Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Community Health Care
  • Drug: Coartem and amoxicillin
  • Drug: Coartem
  • Experimental: Give treatment normally given at rural health center
  • Active Comparator: Give community health post treatment
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
2931
November 2009
 

Inclusion Criteria:

  • Age between 6 months and 5 years
  • Present with history of fever or reported fever
  • Present with cough or difficult breathing

Exclusion Criteria:

  • Age below 6 months and above 5 years
  • Presence of signs and symptoms of severe illness
Both
6 Months to 5 Years
No
Contact: Kojo Yeboah-Antwi, MD, MPH 617-414-1275 kyantwi@bu.edu
Contact: Davidson Hamer, MD 617-414-1267 dhamer@bu.edu
Zambia
 
NCT00513500
 
GHS-A-00-00020-00-5
Boston University
  • Center for International Health and Development
  • United States Agency for International Development (USAID)
Principal Investigator: Kojo Yeboah-Antwi, MD, MPH Center for International Health and Development
Boston University
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP