Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs

NCT00720811 | Completed DMC

• 1 other identifier: A60487
• Study Type: interventional
• Target: 6,456
• Locations: 3 countries
• Sites: 4

Brief Summary

This study is to assess the value of incorporating a malaria RDT based strategy in HMM. The primary activity of the study wil be a two armed cluster randomised trial in two study sites in Uganda, one in Ghana and one in Burkina Faso. One of the Uganda sites is highly endemic and the other meso-endemic for malaria. In one arm the children will be treated presumptively for malaria with ACT (control arm) and the other arm the children will receive ACT only when they have a positive RDT result (implementation arm). The children in the implementation arm will also receive antibiotics if they have a raised respiratory rate. The primary outcome will be the recovery rate in the intervention arm compared to that of the control arm on Day 3. In addition, an acceptability assessment of RDTs in the community will be undertaken both before and after the intervention trial and a cost-effectiveness analysis of the RDT strategy will also be completed. For a sub-sample, microscopy slides will also be taken on Day 0 to demonstrate comparable levels of endemicity in control and intervention groups. These activities will be carried out over a two year period.

Conditions

Malaria; Pneumonia

Keywords

Malaria ACT; Rapid; Diagnosis; Community; health; worker; Artemesinin; based; Combination; Therapy; Anti Malarial; Treatment; antibiotics

Outcome Measures

Primary Outcomes (1)

• Recovery rate from fever at Day 3

  Day 3

Secondary Outcomes (2)

• use of antimalarial and antibiotic drugs by community health workers

  After patient enrollment

• Recovery rate from fever at Day 7

  Day 7

Study Arms (2)

ACT, antibiotic, paracetamol

EXPERIMENTAL

CHWs will test children with acute febrile illness for malaria using RDTs, and for pneumonia by counting their respiratory rate with RRTs. Treatment will then be provided on the basis of the test results, in line with national guidelines. Children with a positive RDT will receive artemether-lumefantrine in Burkina Faso and Uganda, and artesunate-amodiaquine in Ghana. Children with a cough and a high respiratory rate will receive amoxicillin in Ghana and Uganda, and cotrimoxazole in Burkina Faso. Additionally, paracetamol (PCT) will be provided to all children with an axillary temperature \> 38.5°C.

Drug: Artemether-lumefantrine combination; Drug: amoxycillin; Drug: paracetamol; Device: malaria rapid diagnostic test, respiratory rate timer

Presumptive fever management

NO INTERVENTION

Presumptive treatment of malaria with ACTs. No antibiotic treatment available

Drug: Artemether-lumefantrine combination

Interventions

Artemether-lumefantrine combination DRUG

20/120mg Artemether-lumefantrine 4-35 months: 1 tablet twice daily for 3 days; 36-59 months: 2 tablets twice daily for 3 days

Also known as: Coartem

ACT, antibiotic, paracetamol

amoxycillin DRUG

amoxycillin 250mg tab 4-12 months: 1/2x2; 13-35 months: 1x2; 36-59 months: 11/2x2

ACT, antibiotic, paracetamol

paracetamol DRUG

paracetamol 500mg tablet \<36months: 1/4x4 for 2 days; 36-59months: 1/2x4 for 2 days

ACT, antibiotic, paracetamol

malaria rapid diagnostic test, respiratory rate timer DEVICE

malaria dipstick, and breath timer

ACT, antibiotic, paracetamol

Eligibility Criteria

• Age: 4 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between 4-59 months of age with a history of fever in the last 24 hours presenting to the community medicine distributor

You may not qualify if:

• Children classified as having severe illness according to IMCI guidelines. Children suffering from Chronic disease(s), those with reported anti malarial or antibiotic treatment (intervention) arm in previous two weeks and those whose caregivers refuse to consent to participate

Sponsors & Collaborators

• Mbarara University of Science and Technology: lead
• Makerere University: collaborator
• Ministry of Health, Uganda: collaborator
• Navrongo Health Research Centre, Ghana: collaborator
• National Malaria Research and Training Centre, Burkina Faso: collaborator

Study Sites (4)

Sapone Site

Saponé, Burkina Faso

Location

Kassena Nankana Site

Kassane, Ghana

Location

Iganga Site

Iganga, Uganda

Location

Mbarara Site

Mbarara, Uganda

Location

MeSH Terms

Conditions

Malaria; Pneumonia; Fasting; Disease

Interventions

Artemether, Lumefantrine Drug Combination; Amoxicillin; Acetaminophen

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Feeding Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Aniline Compounds; Amines

Study Officials

• Francis Bajunirwe, MBChB PhD

  Mbarara University of Science and Technology

  STUDY DIRECTOR

• George Pariyo, MB ChB, PhD

  Makerere University

  STUDY DIRECTOR

• James Tibenderana, MB ChB, PhD

  Malaria Consortium

  PRINCIPAL INVESTIGATOR

• Alfred Tiono, PhD

  National Malaria Research and Training Center, Burkina Faso

  PRINCIPAL INVESTIGATOR

• Thomas Anyorigiya, MSc

  Navrongo Health Research Centre, Ghana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 23, 2008
• Study Start: October 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

GH (1); BU (1); UG (2)