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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014