NCT00493922

Brief Summary

1\) To compare in a setting where microscopy for malaria is available whether introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v microscopy). 2) To compare whether, in a setting where microscopy for malaria is not available, introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v clinical diagnosis).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7,263

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2007

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

First Submitted

Initial submission to the registry

June 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2007

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

June 28, 2007

Last Update Submit

January 11, 2017

Conditions

MalariaBacterial Infections

Keywords

MalariaDiagnosisRapid diagnostic testsMicroscopyClinical diagnosisAfrica

Outcome Measures

Primary Outcomes (1)

  • The proportion of RDT test-negative patients who are prescribed an antimalarial in two settings: where there is microscopy and where diagnosis is on clinical basis

    Two years

Secondary Outcomes (3)

  • Proportion of RDT test-positive patients who were not prescribed an antimalarial in both settings

    Two years

  • Proportion of clinic microscopy slide-negative patients who were prescribed an anti-malarial in the setting with microscopy available

    Two years

  • Proportion of patients receiving additional or alternative treatments to antimalarials following a negative RDT result and which treatments these are.

    Two years

Study Arms (3)

2

ACTIVE COMPARATOR

Microscopy for diagnosis of malaria

Procedure: Microscopy

3

ACTIVE COMPARATOR

Clinical diagnosis for malaria

Procedure: Clinical diagnosis for malaria

1

EXPERIMENTAL

Rapid Diagnostic Test for Malaria

Procedure: Rapid diagnostic test

Interventions

Rapid diagnostic testPROCEDURE

Introduction of rapid diagnostic test for malaria

1
MicroscopyPROCEDURE

Microscopy for diagnosis of malaria

2
Clinical diagnosis for malariaPROCEDURE

The use of Clinical diagnosis for the diagnosis of malaria

3

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinician decision to test for malaria

You may not qualify if:

  • Pregnant women
  • Severe malaria requiring referral
  • Patient refuses consent
  • Clinician specifically requests for microscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dangme West District

Dodowa, Greater Accra Region, Ghana

Location

Related Publications (1)

  • Ansah EK, Narh-Bana S, Epokor M, Akanpigbiam S, Quartey AA, Gyapong J, Whitty CJ. Rapid testing for malaria in settings where microscopy is available and peripheral clinics where only presumptive treatment is available: a randomised controlled trial in Ghana. BMJ. 2010 Mar 5;340:c930. doi: 10.1136/bmj.c930.

    PMID: 20207689DERIVED

MeSH Terms

Conditions

MalariaBacterial InfectionsDisease

Interventions

Rapid Diagnostic TestsMicroscopy

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesBacterial Infections and MycosesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesPoint-of-Care TestingPoint-of-Care SystemsPatient Care ManagementHealth Services AdministrationDiagnostic Imaging

Study Officials

  • Evelyn K Ansah, MD MPH PhD

    Ghana Health Services

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 28, 2007

First Posted

June 29, 2007

Study Start

July 1, 2007

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

GH(1)