A multi-centric trial of front-loaded smear microscopy in the diagnosis of tuberculosis

• Register: ISRCTN
• Last refreshed on: 28 November 2016
• Main ID: ISRCTN53339491
• Date of registration: 08/04/2008
• Prospective Registration: No
• Primary sponsor: Liverpool School of Tropical Medicine (UK)
• Public title: A multi-centric trial of front-loaded smear microscopy in the diagnosis of tuberculosis
• Scientific title: A multi-centric trial of front-loaded smear microscopy in the diagnosis of tuberculosis
• Date of first enrolment: 06/01/2008
• Target sample size: 6852
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN53339491
• Study type: Interventional
• Study design: Interventional randomised controlled two-armed study (Diagnostic)
• Phase: Not Specified

Countries of recruitment

Brazil, Ethiopia, Nepal, Nigeria, Yemen

Contacts

• Name: Luis Cuevas

Key inclusion & exclusion criteria

Inclusion criteria: 1. Symptoms suggesting pulmonary TB: persistent cough (generally greater than two weeks)
2. Provision of informed consent to participation
3. Age greater than 18 years old, either sex
Exclusion criteria: 1. Inability to provide informed consent (e.g., unfamiliarity with language of patient information/consent forms, prisoners, mentally impaired)
2. Anti-tuberculous treatment in the last month

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis
Infections and Infestations
Tuberculosis

Intervention(s)

Scheme one: experimental arm -
Each patient attending during this week will be requested to provide:
1. One on-the-spot sputum sample at the time of the patient's first visit
2. A second on-the-spot sample taken one hour after the first one
3. An early morning sputum sample taken by the patient at home on the day following the initial visit

Scheme two: current standard -
Each patient attending during this week will be requested to provide:
1. One on-the-spot sputum sample at the time of the patient's first visit
2. An early morning sputum sample taken by the patient at home on the day following the initial visit
3. A second on-the-spot sample taken at the time the patient brings his early morning sample

There is no long term follow up of patients. Patients are managed by the National TB control programmes. It is intended that enrolment of patients will take a minimum of 10 months and may continue until the sample size is complete.

Primary Outcome(s)

These outcomes will be established for each diagnostic strategy and will use culture as gold standard:
1. Sensitivity, specificity, positive and negative predictive value of smear microscopy when using:
1.1. The WHO case definitions for smear-positive tuberculosis
1.2. The first two specimens collected by each strategy (spot and extra-spot versus spot and morning)
2. The number of patients referred to a TB treatment centre 24, 48 and 72 hours after their initial consultation
3. The number of patients who drop out of the diagnostic process

Secondary Outcome(s)

1. Sensitivity, specificity, positive and negative predictive value of:
1.1. A single positive smear
1.2. A single positive smear considering smears with scanty acid-fast bacilli (AFB) as positive
1.3. The smears collected as spot, extra-spot and morning or spot-morning-spot
2. Proportion of patients with positive culture identified by two smears prepared from a single specimens
3. The incremental yield of the second and third samples

Secondary ID(s)

07.35; A70394

Source(s) of Monetary Support

United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)