NCT02151578

Brief Summary

A well-implemented community-based program of early and appropriate treatment of fevers/malaria episodes and pneumonia,will improve child survival as measured by a reduction of the less than five mortality rate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
Last Updated

May 30, 2014

Status Verified

May 1, 2014

Enrollment Period

3.4 years

First QC Date

May 27, 2014

Last Update Submit

May 29, 2014

Conditions

MalariaPneumonia

Keywords

Impact of home management of malaria and pneumonia on child mortalityhome management of malaria and pneumonia

Outcome Measures

Primary Outcomes (1)

  • Number of death in children aged 6 to 59 months

    annual crude mortality rate in children aged 0 to 6 months in the different study arms

    12 months

Secondary Outcomes (1)

  • - specific mortality preceded by acute febrile illness of children aged 6 to 59 months - severe malaria cases at community level

    12 months

Other Outcomes (1)

  • Adverse events at community level consecutive to the administration of the cotrimoxazole and arthemeter/lumefantrine

    7 days after the administration of the drug

Study Arms (3)

nothing at home level

NO INTERVENTION

No intervention at community level. The study drugs (arthemeter/Lumefantrine and Cotrimoxazole) available at the health facility drug stores level and prescribed exclusively to sick children attending to the health facility for care seeking. No Community Heath Worker /Key Opinion leader (CHWs/KOLs) selected in those clusters

Home management of malaria

EXPERIMENTAL

At the community level, the Community health workers/ keay opinion leader (HWs/KOLs) trained and equipped to provide the antimalarial drug (arthemeter/Lumefantrine ) to any child with fever ("hot body") without any other signs of complications like impaired consciousness, convulsions, etc

Other: home/community case management

Home management of malaria and pneumonia

EXPERIMENTAL

At the community level, the Community health workers/ key opinion leader (HWs/KOLs) trained and equipped to provide the antimalarial drug (arthemeter/Lumefantrine ) or antibiotic (Cotrimoxazole) to any child with fever ("hot body") without any other signs of complications like impaired consciousness, convulsions, etc. The treatment decision making for the CHWs/KOLs based on the algorithm

Other: home/community case management

Interventions

home/community case managementOTHER
Home management of malariaHome management of malaria and pneumonia

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • living in one of the study cluster (villages)
  • no story of allergy to any of the study drugs
  • history of fever or body temperature \>= 38.5°C

You may not qualify if:

  • signs of severity/complications like impaired consciousness, convulsions, fast breathing etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe de Recherche Action en Sante (GRAS sarl)

Ouagadougou, Kadiogo, Burkina Faso

Location

Related Publications (1)

  • Oliphant NP, Manda S, Daniels K, Odendaal WA, Besada D, Kinney M, White Johansson E, Doherty T. Integrated community case management of childhood illness in low- and middle-income countries. Cochrane Database Syst Rev. 2021 Feb 10;2(2):CD012882. doi: 10.1002/14651858.CD012882.pub2.

    PMID: 33565123DERIVED

MeSH Terms

Conditions

MalariaPneumonia

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sodiomon Bienvenu SIRIMA, MD, PhD

    Groupe de Recherche Action en santé (GRAS), 06 BP 10248 Ouagadougou 06, Burkina Faso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 27, 2014

First Posted

May 30, 2014

Study Start

January 1, 2009

Primary Completion

June 1, 2012

Study Completion

September 1, 2012

Last Updated

May 30, 2014

Record last verified: 2014-05

Locations

BU(1)