Trial of Rapid Diagnostic Tests in Rural Ghana (RDT)

This study has been completed.
Sponsor:
Collaborators:
Ghana Health Services
London School of Hygiene and Tropical Medicine
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00493922
First received: June 28, 2007
Last updated: July 2, 2009
Last verified: June 2007
  Purpose

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).


Condition Intervention Phase
Malaria
Bacterial Infections
Procedure: Rapid diagnostic test
Procedure: Microscopy
Procedure: Clinical diagnosis for malaria
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: An Individually Randomised Trial of Rapid Diagnostic Tests in Rural Ghana

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • 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 [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of RDT test-positive patients who were not prescribed an antimalarial in both settings [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
  • Proportion of clinic microscopy slide-negative patients who were prescribed an anti-malarial in the setting with microscopy available [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
  • Proportion of patients receiving additional or alternative treatments to antimalarials following a negative RDT result and which treatments these are. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Enrollment: 7263
Study Start Date: July 2007
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Microscopy for diagnosis of malaria
Procedure: Microscopy
Microscopy for diagnosis of malaria
Active Comparator: 3
Clinical diagnosis for malaria
Procedure: Clinical diagnosis for malaria
The use of Clinical diagnosis for the diagnosis of malaria
Experimental: 1
Rapid Diagnostic Test for Malaria
Procedure: Rapid diagnostic test
Introduction of rapid diagnostic test for malaria

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinician decision to test for malaria

Exclusion Criteria:

  • Pregnant women
  • Severe malaria requiring referral
  • Patient refuses consent
  • Clinician specifically requests for microscopy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493922

Locations
Ghana
Dangme West District
Dodowa, Greater Accra, Ghana
Sponsors and Collaborators
Gates Malaria Partnership
Ghana Health Services
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Evelyn K Ansah, MD MPH PhD Ghana Health Services
  More Information

Additional Information:
No publications provided by Gates Malaria Partnership

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Evelyn Korkor Ansah, Ghana Health Service
ClinicalTrials.gov Identifier: NCT00493922     History of Changes
Other Study ID Numbers: REG-8
Study First Received: June 28, 2007
Last Updated: July 2, 2009
Health Authority: Ghana: Ministry of Health

Keywords provided by Gates Malaria Partnership:
Malaria
Diagnosis
Rapid diagnostic tests
Microscopy
Clinical diagnosis
Africa

Additional relevant MeSH terms:
Bacterial Infections
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on April 14, 2014