NL-OMON47928
Recruiting
Phase 2
A prospective, randomized pilot study of the immunomodulatory effects of azithromycin in adults with pulmonary tuberculosis - AZT_DSTB_BB
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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