Condition category
Infections and Infestations
Date applied
14/06/2010
Date assigned
04/03/2011
Last edited
04/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elizeus Rutebemberwa

ORCID ID

Contact details

Makerere University School of Public Health
Mulago Hospital Complex
Upper Mulago Hill
Kampala
4147072
Uganda

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

http://www.uncst.go.ug/

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

Publication citations

Additional files

Editorial Notes