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

Conditions

Tuberculosis Infections and Infestations Tuberculosis

Cuevas LE, Al-Sonboli N, Lawson L, Yassin MA, Arbide I, Al-Aghbari N, Sherchand JB, Al-Absi A, Emenyonu EN, Merid Y, Okobi MI, Onuoha JO, Aschalew M, Aseffa A, Harper G, de Cuevas RM, Theobald SJ, Nathanson CM, Joly J, Faragher B, Squire SB, Ramsay A.

2011-07-1251 citations

10.1371/journal.pmed.1001057

A multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis.

Cuevas LE, Yassin MA, Al-Sonboli N, Lawson L, Arbide I, Al-Aghbari N, Sherchand JB, Al-Absi A, Emenyonu EN, Merid Y, Okobi MI, Onuoha JO, Aschalew M, Aseffa A, Harper G, de Cuevas RM, Kremer K, van Soolingen D, Nathanson CM, Joly J, Faragher B, Squire SB, Ramsay A.

2011-07-1242 citations

10.1371/journal.pmed.1000443

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Brazil, Ethiopia, Nepal, Nigeria, Yemen

Outcome results

None listed