Zambia Integrated Management of Malaria and Pneumonia Study (ZIMMAPS)

This study has been completed.
Sponsor:
Collaborators:
Center for International Health and Development
United States Agency for International Development (USAID)
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00513500
First received: August 7, 2007
Last updated: July 13, 2010
Last verified: July 2010

August 7, 2007
July 13, 2010
June 2007
February 2009   (final data collection date for primary outcome measure)
  • Number of Children Who Received Early and Appropriate Treatment for Pneumonia. [ Time Frame: one year ] [ Designated as safety issue: No ]
    Early and appropriate is defined as receiving 13-15 doses of amoxicillin over 5 days and receiving the first dose within 24-48 hours of onset of first symptom
  • Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • 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 ]
Complete list of historical versions of study NCT00513500 on ClinicalTrials.gov Archive Site
Number of Children Who do Not Respond to Treatment for Pneumonia [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
Not Provided
 
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
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Pneumonia
  • Malaria
  • Drug: Coartem and amoxicillin
    Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing
  • Drug: Coartem
    Give Coartem without RDT and refer fast breathing
  • Experimental: 1
    Give one half tablet (20mg artemether, 120mg lumefantrine) to children weighing (5-9.9kg) and one tablet to children weighing (10-20kg) twice a day for three days for malaria based on rapid diagnostic test. For pneumonia, give one half tablet (250mg amoxicillin) for children weighing (5-9.9kg) and one tablet for children weighing (10-20kg) three times a day for five days.
    Intervention: Drug: Coartem and amoxicillin
  • Active Comparator: 2
    Give one half tablet (20mg artemether, 120mg lumefantrine) to children weighing (5-9.9kg) and one tablet to children weighing (10-20kg) twice a day for three days for malaria based on clinical diagnosis. For pneumonia, refer to the nearest health facility
    Intervention: Drug: Coartem
Yeboah-Antwi K, Pilingana P, Macleod WB, Semrau K, Siazeele K, Kalesha P, Hamainza B, Seidenberg P, Mazimba A, Sabin L, Kamholz K, Thea DM, Hamer DH. Community case management of fever due to malaria and pneumonia in children under five in Zambia: a cluster randomized controlled trial. PLoS Med. 2010 Sep 21;7(9):e1000340.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3125
September 2009
February 2009   (final data collection date for primary outcome measure)

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 information is only displayed when the study is recruiting subjects
Zambia
 
NCT00513500
GHS-A-00-00020-00-5
Yes
Kojo Yeboah-Antwi, Center for International Health and Development
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
July 2010

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