Zambia Integrated Management of Malaria and Pneumonia Study

NCT ID: NCT00513500

Last Updated: 2010-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-09-30

Brief Summary

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.

Detailed Description

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..

Conditions

Pneumonia; Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Coartem and amoxicillin

Intervention Type: DRUG

Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing

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

Group Type: ACTIVE_COMPARATOR

Coartem

Intervention Type: DRUG

Give Coartem without RDT and refer fast breathing

Interventions

Coartem and amoxicillin

Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing

Intervention Type: DRUG

Coartem

Give Coartem without RDT and refer fast breathing

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for International Health and Development

OTHER

Sponsor Role: collaborator

United States Agency for International Development (USAID)

FED

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Center for International Health and Development

Principal Investigators

Kojo Yeboah-Antwi, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Center for International Health and Development

Locations

Chikankata Health Services

Chikankata, Southern Province, Zambia

Countries

Zambia

References

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. doi: 10.1371/journal.pmed.1000340.

Reference Type: DERIVED

PMID: 20877714 (View on PubMed)

Other Identifiers

GHS-A-00-00020-00-5

Identifier Type: -

Identifier Source: org_study_id