A double-blind, randomized, stratified, multi-center trial evaluating conventional and high dose oseltamivir in the treatment of immunocompromised patients with influenza.
- Conditions
- Treatment of influenza in immunocompromised patients.MedDRA version: 14.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2006-002468-24-IT
- Lead Sponsor
- ROCHE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 215
• Age greater than or equal to 1 year; • Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours prior to first dose; • Immunocompromised subject defined as one who meets any of the following: o Primary immunodeficiency at risk for viral infections (representative examples in Appendix 6) OR o Secondary immunodeficiency ô??? SOT with ongoing immunosuppression OR ô??? Allogenic HSCT with ongoing immunosuppression OR ô??? HIV with CD4 count < 200/mm3 OR ô??? Hematologic malignancies (representative examples in Appendix 7) OR ô??? Systemic (e.g. enteric, sc, im or iv) immunosuppressive therapy, irrespective of medical indication, started at least 12 weeks prior to, and ongoing at the time of first dose of study drug (representative examples in Appendix 8) • Symptoms suggestive of influenza like illness including, but not limited to fever, cough, or coryza; • In patients with history or clinical presentation at randomization suggestive of renal failure; a CrCl > 60 ml/min/1.73M2; • Less than or equal to 96 hours between onset of influenza like illness and first dose of study drug; • Parent/guardian willing and able to comply with study requirements and give consent, (country specific age cut off) • Patient able to comply with study requirements and willing to give assent, as appropriate (country specific age cut off); • For adult patients, willing and able to comprehend and give written informed consent; • Patients, in the reproductive age group, must agree to utilize an effective method of contraception throughout the study period and for females for one reproductive cycle following cessation of study therapy; • Females of childbearing potential must have a negative urine pregnancy test prior to start of study medication
Are the trial subjects under 18? yes
Number of subjects for this age range: 55
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 74
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37
• SOT within 6 months of the time of randomization; • Have in the investigator`s opinion experienced acute rejection in the 4 weeks prior to randomization; • HSCT patients with no evidence of engraftment (engraftment is defined as the point at which a patient can maintain a sustained absolute neutrophil count (ANC) of > 500/mm3 and sustained platelet count of `?¥ 20,000/mm3, lasting `?¥ 3 consecutive days without transfusions). • HSCT subjects not discharged from hospital after their initial hospitalization for transplantation. • Have clinical evidence for hepatic decompensation at the time of randomization (clinical icterus, ascites, hepatic encephalopathy, coagulopathy). • Have cirrhosis of the liver at the time of randomization. • Patients currently receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis or hemofiltration. • Have evidence of active or uncontrolled opportunistic infections (bacterial, fungal, or viral-including cytomegalovirus [CMV] or polyoma virus [BKV]) at the time of randomization. Patients with HCV or HBV are not excluded. • Patients with co-morbid conditions which are uncontrolled. Uncontrolled is defined as disease requiring change of therapy or hospitalization in the 4 weeks preceding randomization. Change of therapy is defined as dose increase or change of medication prior to onset of present influenza like illness. • Patients with gastrointestinal disorders which might interfere with their ability to absorb oral medication. • Allergy to the test medication. • Patients with hereditary fructose intolerance (for subjects who will be taking the liquid formulation). • Influenza vaccination with live attenuated vaccine in the 2 weeks prior to randomization. • Antiviral treatment (example: amantadine, rimantadine, oseltamivir, laninamivir, peramivir, zanamivir and ribavirin) for influenza in the 2 weeks prior to randomization. • Patients taking probenecid medication. • Patients who are pregnant or breast-feeding. • Participation in a clinical trial or expanded access trial with an investigational drug in the 4 weeks prior to randomization or concomitantly with this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate prospectively the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromized patients and characterize the effects of oseltamivir in immunocompromized patients on the development of resistant influenza virus;Secondary Objective: • The time to resolution of influenza symptoms • The clinical course of influenza (fever, symptoms, secondary illnesses as evidenced by otitis media, bronchitis, pneumonia, or sinusitis) • The virologic course of influenza (proportion shedding and viral loads at different time points);Primary end point(s): The primary endpoints are safety and development of resistance.;Timepoint(s) of evaluation of this end point: Time points up to day 40.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - The time to alleviation of all clinical influenza symptoms - Shedding virus at day 1, 2, 6, 8, 11, 15 and 40 - Viral load at day 1, 2, 6, 8, 11, 15 and 40 - The time until resolution of fever - Development of secondary illnesses at any time during the study - Development of secondary illnesses at any time during the study that are treated with antibiotics - Initiation of treatment with antibiotics after randomization;Timepoint(s) of evaluation of this end point: Time points up to day 40.