Evaluation of the treatment for Pneumocystis jirovecii in patients with chronic obstructive pulmonary disease.

• Conditions: Chronic obstructive pulmonary disease; MedDRA version: 14.1Level: PTClassification code 10064107Term: Pneumocystis jiroveci infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-001585-14-ES
• Lead Sponsor: FISEVI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-29
• Last Update Posted: 11 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

? Patients over 39 years old.
? Patients who have not submitted an exacerbation in the last 4 months.
? Possibility of obtaining a sample of sputum or oropharyngeal wash samples
? Informed consetn form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 23
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

? Confirmed diagnosis or suspicion of cancer
? Presence of autoimmune diseases or asma
? Patients infected with HIV
? Use of immunosuppressive or treatment with inhaled corticosteroids
? Presence of exacerbation and / or pneumonia
? Patients with other significant diseases that non-COPD.
? Patients with anemia, leukopenia or thrombopenia
? Patients with impaired renal function (serum creatinine 1.5 x upper limit of normal)
? Patients with diagnosis of liver cirrhosis or chronic hepatitis
? Pregnant, nursing or childbearing women who are not using contraception method at least in previous three months of the trial during this.
? Participation in another trial with an IMP in 30 days previous or 6 semividas (the larger of both)
? Hipersensibility to atovaquone
? Lost follow-up

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified