Mycobacteriosis Infections and Infestations Bacteriosis
Conditions
Interventions
Two parallel groups:
Group one: Antibiotic chemotherapy and interferon gamma
Group two: Antibiotic chemotherapy and placebo
Treatment lasted six months, and a further follow up of 12 months occurred.
Sponsors
Centre for Genetic Engineering and Biotechnology (Centro de Ingeniería Genética y Biotecnología) (Cuba)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient's written informed consent 2. To fulfil diagnostic criteria: a. isolation and typification, at least three times, in sputum samples of any of the following species: M. Avium-intracellulare, M. Kansasii, M. Xenopi, M. Marinum, M. fortuitum-chelonae, M. simiae, M. Scrofulaceum, M. Szulgai, M. Gorddonae, M. Flavescans, M. Gastri, M. Triviale, M. Vaccae, M. Smegmatis or M. Phlei b. presence of respiratory symptoms such as cough and expectoration c. tuberculosis-like lesions at thorax radiography 3. Aged more than 18 years old 4. In case of fertile women, to use a non-hormone anti-conception method 5. Not having received any type of interferon during the previous three months
Exclusion criteria
Exclusion criteria: 1. Any other respiratory infection 2. Severe cardiovascular disease 3. Renal or liver failure 4. Malignancies, except for skin basal cell carcinoma and in situ cervix carcinoma 5. Pregnancy or breast-feeding 6. Human Immunodeficiency Virus (HIV) co-infection 7. Hypersensitivity to interferon or other components of the formulations used 8. Treatment with glucocoticoids or other immunosuppressor medication 9. Functional central nervous system alterations 10. Multiple sclerosis or other auto-immune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite variable that includes clinical, bacteriological and radiological outcomes: 1. Complete response: a. disappearance of all symptoms b. negative sputum acid-fast-bacilli smear and culture c. pulmonary lesions improvement at X-ray 2. Partial response: a. symptoms decrease b. negative sputum smear and culture c. stable or improvement at X-ray 3. No response: a. symptoms persistence b. positive bacteriological examinations c. lesion progression at X-ray | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. General clinical status: a. good: none or discreet respiratory symptoms without frequent or serious exacerbations, appropriate body weight b. moderate: maintained respiratory symptoms with more acute exacerbations, appropriate body weight c. bad: maintained serious respiratory symptoms (intense dyspnea, cough, and abundant expectoration), low body weight 2. Dyspnea perception: a. score 0: no dyspnea at all b. score 1: dyspnea while climbing hills or stairs c. score 2: dyspnea while walking at a rapid pace on ground level d. score 3: dyspnea while walking at own pace on ground level e.score 4: dyspnea at rest 3. Bacteriology: sputum direct observation and culture: positive or negative 4. Radiology: a. lesions extension: i. minimum: if they comprised up to one third of a lung area ii. moderate: up to one lung involvement iii. advanced: more than one lung involved b. presence of cavitations 5. Time to overall and each response 6. Clinical laboratory variables: a. haematocrit b. globular sedimentation rate | — |
Countries
Cuba
Outcome results
None listed