Rapid Diagnosis of Pulmonary Tuberculosis
Information source: University of Cape Town
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tuberculosis
Intervention: Salbutamol (Drug); Sodium chloride 5% (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: University of Cape Town Overall contact:
Mark Hatherill, Phone: +27 21 4066697
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.
Clinical Details
Official title: Diagnostic Yield of Induced Sputum for Rapid Diagnosis of Pulmonary Tuberculosis
Study design: Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary outcome: Sputum direct smear positive for acid-fast bacilli.
Secondary outcome: Sputum culture positive for Mycobacterium tuberculosis.
Detailed description:
Early case detection, treatment, and prompt household contact investigation, depend on rapid
microbiological confirmation, by direct smear microscopy of acid-fast bacilli, in patients
with suspected pulmonary tuberculosis. Since delayed diagnosis may result in death due to
lack of appropriate therapy, rapid microbiological diagnosis is especially critical in
HIV-infected persons. Improved rapid diagnostic methods are also crucial for the success of
epidemiological studies; trials of preventative interventions, such as novel vaccines; and
therapeutic interventions, since the diagnostic endpoints of such trials may require
microbiological confirmation of tuberculosis. In clinical practice, early therapeutic
intervention might reduce the risk of death, especially in patients co-infected with HIV. In
this study, researchers propose to test a simple diagnostic modality for rapid diagnosis of
pulmonary tuberculosis in HIV-infected and HIV-uninfected adolescents and adults. Researchers
will test whether induced sputum will improve the diagnostic yield of smear positive
tuberculosis. This low-cost technology augments spontaneous sputum production by inhalation
of a nebulized saline solution. The primary objective of this study is to quantify and
compare the diagnostic yield of smear positive tuberculosis from induced sputum, with that of
routine sputum, in HIV-infected patients with suspected tuberculosis. Researchers believe
that induced sputum will increase the diagnostic yield from direct smear microscopy in this
patient population. The secondary objective of the study is to quantify and compare the
diagnostic yield of smear positive tuberculosis from induced sputum, with that of routine
sputum, in all patients with suspected tuberculosis, regardless of HIV status. Researchers
believe that induced sputum will increase the diagnostic yield from direct smear microscopy
in all patients in this population, regardless of HIV status. Approximately 1200 individuals
(male or female gender), aged 12 years and older, with suspected pulmonary tuberculosis, will
be screened in order to enroll 600 eligible participants at 2 district health services
clinics near the town of Worcester, Western Cape Province, South Africa. Informed consent for
participation will be sought from adolescents and adults with suspected pulmonary
tuberculosis who present to public sector community health services for investigation. A
rapid HIV test, with pre- and post-test counseling, will be performed. A routine spontaneous
expectorated sputum sample and an induced sputum sample (obtained after nebulization of
sterile 5% saline via mask) will be collected. A second routine sputum will be collected on
the following morning. Direct smear microscopy and mycobacterial culture of sputum will be
performed in an accredited microbiology laboratory. HIV rapid test results will be used to
classify participants for evaluation of the primary outcome, positive direct smear
microscopy, and the secondary outcome, positive culture of M. tuberculosis. Diagnostic yields
for each routine and induced sputum sample will be calculated, as a proportion of all
patients who are culture-positive for M. tuberculosis, and compared in a pair-wise and
sequential manner. Results will be reported as differences in yield and 95% confidence
intervals for the difference in those proportions. The primary endpoint will be sputum direct
smear microscopy positive for acid-fast bacilli. The secondary endpoint will be sputum
culture positive for Mycobacterium tuberculosis. Study duration will be 4 years with
individual subject participation approximately 8 weeks.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Mark Hatherill, Phone: +27 21 4066697
University of Cape Town, Cape Town, South Africa
Additional Information
Ending date: May 2012
Last updated: July 29, 2008
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