Azithromycin as Host-directed Therapy for Pulmonary Tuberculosis
Status:
Unknown status
Trial end date:
2020-04-30
Target enrollment:
Participant gender:
Summary
Rationale:
Treatment in tuberculosis (TB) is focused on eradication of the bacterial infection, however,
after treatment approximately half of patients are left with a significant and permanent
respiratory impairment. Adjunctive host-directed therapies are being investigated to modulate
host immune responses to target mycobacterium tuberculosis (Mtb) infection and/or reduce
excessive inflammation, prevent pathological tissue damage, preserve lung function and
enhance effectiveness of standard drug therapy, while nonetheless eliminating Mtb. Macrolide
antibiotics have previously been used in the treatment of multidrug-resistant TB. In addition
to their antibiotic effects, macrolides have also been recognized to induce anti-inflammatory
and immunomodulatory effects in other lung diseases.
Objective:
To investigate the immunomodulatory effects of azithromycin in tuberculosis patients
receiving standard therapy (isoniazid, rifampicin, pyrazinamide, ethambutol (HRZE))
Study design:
A prospective, randomized open label intervention trial to investigate the immunomodulatory
effects of azithromycin
Study population: 24
Intervention: azithromycin 250 mg once daily or standard of care (control)
Main study parameters/endpoints:
1. To assess whether azithromycin enhances resolution of systemic inflammation in patients
with drug susceptible pulmonary TB receiving standard treatment.
2. To assess whether azithromycin on top of standard treatment in patients with drug
susceptible pulmonary TB reduces airway inflammation and reduces tissue degradation and
remodeling
3. To investigate whether these effects are associated within shortening of the time to
sputum conversion.