A prospective, randomized pilot study of the immunomodulatory effects of azithromycin in adults with pulmonary tuberculosis

Phase 2

Recruiting

• Conditions: TB; Tuberculosis; 10028440

• Registration Number: NL-OMON47928
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Microbiological proven diagnosis of drug sensitive pulmonary tuberculosis (by culture and/or molecular test.; absence of resistance genes such as rpob, inha, katg)
- Written informed consent

Exclusion Criteria

- Patient reported previous history of treatment for tuberculosis
- Patients younger than 18 years
- Pregnancy or breast feeding
- Patients with hypersensitivity to macrolide antibiotics
- Treatment with any macrolide in the previous month
- Treatment with any tetracycline in the previous month
- Treatment with any inhaled or oral corticosteroid in the previous month
- Concomitant treatment with analgesic (NSAIDs)/immunosuppressant drugs (except paracetamol). See attachment A for a full list of these drugs.
- Treatment with digoxin
- Patients with gastrointestinal complaints, like diarrhea and vomiting (>=grade 2, observed; diarrhea: increase of 4-6 stools per day over baseline; vomiting: >=3-5 episodes (separated by 5 minutes) in 24 hours)
- Other known respiratory diseases, including bronchiectasis, pulmonary fibrosis, pulmonary vascular disease or lung cancer
- HIV-1 infection or AIDS
- Impaired liver function (Child-Pugh score C, for calculation of the score, see attachment B)
- Patients with a known QTc >=500 ms. An electrocardiogram (ECG) will be recorded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective will be studied by measuring total white blood cell<br /><br>count, blood cell differential counts and serum inflammatory markers. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective will be studied by measuring inflammatory cell counts,<br /><br>differential cell counts, cytokines and markers of tissue degradation and<br /><br>remodeling in induced sputum.</p><br>