Tuberculosis Clinical Trial
Official title:
Essentiality of Isoniazid in Tuberculosis Therapy
Tuberculosis (TB) disease is caused by bacteria that have infected the lung. TB bacteria are
very small living agents that are spread by coughing and can be killed by taking TB drugs. To
kill these TB bacteria TB patients have to take a combination of four drugs for 2 months and
then two drugs for a further 4 months. During the first 2 months patients take rifampicin,
isoniazid, ethambutol, and pyrazinamide. After that patients take only isoniazid and
rifampicin for a further 4 months, making a total of 6 months therapy.
In A5307 the investigators wanted to test a new combination of drugs to see if the
investigators could treat TB faster in the future.
Studies in animals have suggested that one of the four drugs, isoniazid, only works for a few
days and may not be needed after the first two doses of TB treatment to kill the TB bacteria.
After that its effects wear off to the point that it may even interfere with the other drugs.
The investigators wanted to see if stopping isoniazid early, or using moxifloxacin, a
different drug, instead could treat TB faster. This study was the first time that this type
of regimen without isoniazid had been tested in humans. If the investigators could show that
isoniazid stops working after a few days, the investigators could then try to see if they
could possibly make a better tuberculosis treatment in the future.
This was a Phase IIa open label, randomized clinical trial comparing the early bactericidal
activity (EBA) of four anti-tuberculosis regimens. Participants with acid fast bacilli (AFB)
smear-positive pulmonary tuberculosis were hospitalized from screening through Day 15 of the
study, during which time, sputum, blood, and urine were collected. Participants returned to
the clinic on Day 28 for the final visit. The study duration was 29 days.
The purpose of the study was to estimate the primary outcome within each study arm and the
study was not designed for between arm comparisons.
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