Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HS 72
Study information
Scientific title
An integrated Management of Malaria and Pneumonia in children under five at home and community level
Acronym
HCMMP
Study hypothesis
Prompt use and compliance with efficacious treatment for both malaria and pneumonia provided at home and community level reduces under five morbidity and mortality significantly and is more cost effective than giving antimalarials alone.
Ethics approval
Uganda National Council for Science and Technology approved on the 17th August 2005 (ref: HS 72)
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Malaria and pneumonia
Intervention
The intervention arm has combined home and community malaria and pneumonia treatment where pre-packaged drugs (anti-malarial and antibiotics) are distributed through trained community medicine distributors. Children who present with fever are given antimalarials (Coartem®) and when they in addition have rapid breathing, they are given antibiotics (amoxycillin).
For the control arm, antimalarials (Coartem®) are distributed by trained community medicine distributors to the children who present with fever. Those who present with rapid breathing are referred to health facilities. The difference between the intervention and control arms is that in the intervention, there is community distribution of antibiotics in addition to the antimalarials while in the control, there is only distribution of antimalarials alone.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Mortality in children under five
Secondary outcome measures
Determined at the end of the two year period:
1. Mortality preceded by an acute febrile illness
2. Severe anaemia
3. Cost-effectiveness of the interventions
4. Equity analysis
Overall trial start date
02/12/2009
Overall trial end date
01/12/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Children aged 4 to 59 months
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
11,000 children monitored over two years
Participant exclusion criteria
Children below 4 months of age or those above 59 months old
Recruitment start date
02/12/2009
Recruitment end date
01/12/2011
Locations
Countries of recruitment
Uganda
Trial participating centre
Makerere University School of Public Health
Kampala
4147072
Uganda
Sponsor information
Organisation
Uganda National Council for Science and Technology (UNCST) (Uganda)
Sponsor details
Plot 3/5/7
Nasser Road
Kampala
4146884
Uganda
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR) (ref: A20141)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary