Pulmonary tuberculosis Infections and Infestations
Conditions
Interventions
This study is a prospective randomized study that will be carried out to evaluate the immunomodulatory effect of azithromycin in tuberculosis patients. A sputum smear microscopy, Xpert MTB/RIF, a myco
Sponsors
Fondation Congolaise Pour La Recherche Médicale
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of drug-sensitive pulmonary tuberculosis (molecular test identification of the Mtb complex; absence of resistance genes such as rpob, inha, katg) 2. Written informed consent
Exclusion criteria
Exclusion criteria: 1. The patient has reported a history of treatment for tuberculosis 2. Patients under 18 years old 3. Pregnancy or breastfeeding 4. Patients with hypersensitivity to macrolide antibiotics 5. Treatment with a macrolide during the previous month 6. Treatment with tetracycline during the previous month 7. Treatment with any inhaled or oral corticosteroid within the previous month 8. Concomitant treatment with analgesics (NSAIDs)/immunosuppressants (except paracetamol) 9. Digoxin treatment 10. Patients with gastrointestinal disorders, such as diarrhea and vomiting (= grade 2, observed) 11. Patients with a history of cholestatic jaundice/liver dysfunction associated with previous use of Azithromycin 12. Other known respiratory diseases, including bronchiectasis, pulmonary fibrosis, disease pulmonary vascular or lung cancer 13. HIV infection or AIDS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following primary outcome measures will be assessed before randomization, week 2, months 1, 2, 6 and 12: 1. Chest radiographic abnormalities measured using chest X-rays 2. Function measured using a pulmonary function test 3. Serum inflammatory cytokine levels measured using Magpix Luminex immunoassay | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be assessed before randomization, week 2, months 1, 2, 6 and 12: 1. Sputum inflammatory cytokine levels measured using Magpix Luminex immunoassay 2. Serum blood cells measured using an automat Cyan Hemato 3. Sputum inflammatory cell count measured using Magpix Luminex immunoassay | — |
Countries
Congo
Contacts
Public ContactFrancine;Francine Ntoumi;Ntoumi
;
Outcome results
None listed