Home and Community Management of Malaria and Pneumonia
| ISRCTN | ISRCTN52966230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52966230 |
| Secondary identifying numbers | HS 72 |
- Submission date
- 14/06/2010
- Registration date
- 04/03/2011
- Last edited
- 29/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Elizeus Rutebemberwa
Scientific
Scientific
Makerere University School of Public Health
Mulago Hospital Complex
Upper Mulago Hill
Kampala
4147072
Uganda
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | An integrated Management of Malaria and Pneumonia in children under five at home and community level |
| Study acronym | HCMMP |
| Study objectives | 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(s) | Uganda National Council for Science and Technology approved on the 17th August 2005 (ref: HS 72) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 02/12/2009 |
| Completion date | 01/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Months |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | 11,000 children monitored over two years |
| Key inclusion criteria | Children aged 4 to 59 months |
| Key exclusion criteria | Children below 4 months of age or those above 59 months old |
| Date of first enrolment | 02/12/2009 |
| Date of final enrolment | 01/12/2011 |
Locations
Countries of recruitment
- Uganda
Study participating centre
Makerere University School of Public Health
Kampala
4147072
Uganda
4147072
Uganda
Sponsor information
Uganda National Council for Science and Technology (UNCST) (Uganda)
Government
Government
Plot 3/5/7, Nasser Road
Kampala
4146884
Uganda
| Website | http://www.uncst.go.ug/ |
|---|---|
"ROR" |
https://ror.org/05jv1pq83 |
Funders
Funder type
Research organisation
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 22/09/2013 | 29/12/2020 | Yes | No |
Editorial Notes
29/12/2020: Publication reference added.
