None listed
Conditions
Interventions
Group 1: Posaconazole (SCH 56592) Type of group
Posaconazole (SCH 56592) 600mg daily (200mg TID), VO, for 16 weeks.
Group name:Group 2: Fluconazole Type of group
Fluconazole 400mg daily (QD), VO, for 16 weeks.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult subjects (men and women) ≥18 years. 2. Diagnosis of acute grade II-IV GVHD or chronic extensive GVHD after allogeneic bone marrow transplantation, requiring doses ≥1mg / kg / day of Methylprednisolone (MPD) or equivalent (IV or VO) and / or antithymocyte globulin (ATG) 3. Grant your informed consent and comply with the dosage, procedures, visits schedules. 4. Use of reliable contraceptive methods in the MEF. 5. Negative serum pregnancy test. 6. Able to take the study medication by VO.
Exclusion criteria
Exclusion criteria: 1. History of proven or probable fungal infection requiring secondary prophylaxis. 2. Suspicion of invasive fungal infection, excluding infection by Pneumocystis carinii. 3. Treatment with steroids at high doses (≥1mg / kg / day MPD or equivalent) and / or ATG for the current episode of GVDH for more than 10 consecutive days. 4. Use of medications with known interactions with Azoles that put the participant´s life at risk. 5. Use of vinca alkaloids or anthracyclines. 6. ECG with QTc prolongation of 20% over normal. 6. Any condition that requires the use of prohibited medications. 7. Disorder or progressive neurological deterioration. 8. Abnormal values of liver function (ALT / AST> 6 times above the normal limit) and creatinine clearance (> 50ml / min). 9. Pregnancy, breastfeeding. 10. History of hypersensitivity or idiosyncratic reactions to Azoles. 11. Use of another antifungal in research. 12. High probability of death within 2 months of admission. 13. Clinical conditions that lead to an assessment of the safety and efficacy of the PI in a difficult manner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Definitions of proven or probable invasive fungal infections according to the EORTC-MSG (Cooperative Group of Invasive Fungal Infections) - MSG (National Institute of Allergy and Infectious Diseases) Measure:Incidence rate of proven or probable invasive fungal infections (IFI). Timepoints:16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:EORTC-MSG criteria, Presence of fungal species without clinical or radiological evidence of infection, Mycotic cultures in blood, ECOG, Graduation and steroid requirements. Measure:Clinical result: Incidence rate of proven / probable / possible IFI according to EORTC-MSG criteria, Time of appearance of IFI, Incidence of IFI in follow-up, Incidence of mucocutaneous or superficial fungal infection, Incidence of fungal colonization, Use of systemic antifungal therapy empirical, Impact of performance status (ECOG), Impact of GVHD (Graduation and steroid requirements). Timepoints:Weeks 16 | — |
Countries
Arabia Saudi
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERÚ S.A.
Outcome results
None listed