Details

Autor(en) / Beteiligte

• Mayosi, Bongani M
• Ntsekhe, Mpiko
• Bosch, Jackie
• Pogue, Janice
• Gumedze, Freedom
• Badri, Motasim
• Jung, Hyejung
• Pandie, Shaheen
• Smieja, Marek
• Thabane, Lehana
• Francis, Veronica
• Thomas, Kandithal M
• Thomas, Baby
• Awotedu, Abolade A
• Magula, Nombulelo P
• Naidoo, Datshana P
• Damasceno, Albertino
• Banda, Alfred Chitsa
• Mutyaba, Arthur
• Brown, Basil
• Ntuli, Patrick
• Mntla, Phindile
• Ntyintyane, Lucas
• Ramjee, Rohan
• Manga, Pravin
• Kirenga, Bruce
• Mondo, Charles
• Russell, James BW
• Tsitsi, Jacob M
• Peters, Ferande
• Essop, Mohammed R
• Barasa, Ayub Felix
• Mijinyawa, Muhammad S
• Sani, Mahmoud U
• Olunuga, Taiwo
• Ogah, Okechukwu
• Adebiyi, Adewole
• Aje, Akinyemi
• Ansa, Victor
• Ojji, Dike
• Danbauchi, Solomon
• Hakim, James
• Matenga, Jonathan
• Yusuf, Salim

Titel

Rationale and design of the Investigation of the Management of Pericarditis (IMPI) trial: A 2 ? 2 factorial randomized double-blind multicenter trial of adjunctive prednisolone andMycobacterium wimmunotherapy in tuberculous pericarditis

Ist Teil von

• The American heart journal, 2013-02, Vol.165 (2), p.109

Ort / Verlag

Philadelphia: Elsevier Limited

Erscheinungsjahr

2013

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• Background In spite of antituberculosis chemotherapy, tuberculous (TB) pericarditis causes death or disability in nearly half of those affected. Attenuation of the inflammatory response in TB pericarditis may improve outcome by reducing cardiac tamponade and pericardial constriction, but there is uncertainty as to whether adjunctive immunomodulation with corticosteroids andMycobacterium w(M. w) can safely reduce mortality and morbidity. Objectives The primary objective of the IMPI Trial is to assess the effectiveness and safety of prednisolone andM. wimmunotherapy in reducing the composite outcome of death, constriction, or cardiac tamponade requiring pericardial drainage in 1,400 patients with TB pericardial effusion. Design The IMPI trial is a multicenter international randomized double-blind placebo-controlled 2 x 2 factorial study. Eligible patients are randomly assigned to receive oral prednisolone or placebo for 6 weeks andM. winjection or placebo for 3 months. Patients are followed up at weeks 2, 4, and 6 and months 3 and 6 during the intervention period and 6-monthly thereafter for up to 4 years. The primary outcome is the first occurrence of death, pericardial constriction, or cardiac tamponade requiring pericardiocentesis. The secondary outcome is safety of immunomodulatory treatment measured by effect on opportunistic infections (eg, herpes zoster) and malignancy (eg, Kaposi sarcoma) and impact on measures of immunosuppression and the incidence of immune reconstitution disease. Conclusions IMPI is the largest trial yet conducted comparing adjunctive immunotherapy in pericarditis. Its results will define the role of adjunctive corticosteroids andM. wimmunotherapy in patients with TB pericardial effusion.