Rapid Diagnosis of Pulmonary Tuberculosis

• Status: Unknown status
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test whether a saline nebulization (breathing in a mist of moist air through a mask) will help an individual cough up a better sputum sample to test for tuberculosis (TB). In addition, this study will test whether samples obtained with saline nebulization are better at finding TB in people with HIV infection. The study will enroll up to 600 individuals, aged 12 and older, with suspected pulmonary TB. Participants will be asked to cough up a sample of sputum into a container. Then, participants will be asked to breathe a mist of moist air from an oxygen mask followed by moist salty air, which will help individuals to cough up a second sputum sample. This mist of moist air will contain salbutamol, a medicine to help open up the airways. The sputum samples will be sent to a laboratory to test for TB. Additionally, participants will be tested for HIV with a blood sample collection. Participants will be involved in study related procedures for up to 61 days.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cape Town
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Albuterol

Criteria

Inclusion Criteria:

Adolescents and adults with suspected pulmonary tuberculosis who are referred, or self-refer, to health services clinics for investigation for tuberculosis, will be eligible to participate.

Exclusion Criteria:

• Failure to obtain informed consent (including failure to consent for either sputum collection procedures or failure to consent for HIV testing);

• Age less than 12 years;

• A history of asthma;

• A history of heart disease;

• A history of cardiac arrhythmia;

• Inability to tolerate sputum induction procedures;

• Inability to return for study follow-up visit;

• Need for hospital-based in-patient treatment or supplemental oxygen therapy;

• Other acute or chronic lung disease that may compromise lung function;

• Current anti-tuberculous therapy.