There is one clinical trial.
The purpose of this study is to assess the safety and tolerability of triple combination antiviral drug (TCAD) for use in immunocompromised patients with Influenza A infection, and to gain data on the effectiveness of TCAD
Inclusion criteria for open-label arm (at least one criteria required): 1. Young age (1-6 years) with any influenza severity, proven or probable influenza A (H1N1)(H274Y); OR 2. History of asthma; OR 3. Older age (≥ 7 years), with no asthma; AND - moderate to severe influenza; AND/OR - failure in randomized study monotherapy arm iii. --- H274Y ---
Description: Abnormal lab data or newly appeared symptoms & signs were considered as AEs. Examined lab data: Blood cell count (WBC, differential count, Red Blood Cell (RBC), Hemoglobin, Hematocrit, Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin Concentration (MCHC), platelets), Chemistry (Cl, bicarbonate (HCO3), K, Na), Renal function test (BUN, Creatinine, Creatinine clearance), Liver function test (AST, Alanine aminotransferase(ALT), T.Bil, gamma-glutamyltransferase)
Measure: Number of Participants With Adverse Events (AEs), Drug Specific AEs or AEs Resulting in Treatment Interruption Time: 30 days after the final dose of study drugDescription: Viral loads were measured by quantitative Polymerase Chain Reaction (PCR) on day 1, 3, 5, 7, 9, 15, 20 and 28, if applicable.
Measure: Number of Participants With Viral Load Decrease as a Function of Time Time: baseline and 28 daysDescription: Viral resistance was assessed within 28 days after drug administration by detecting resistance-conferring mutation genes and compared to the value at baseline.
Measure: Number of Participants With Viral Resistance as a Function of Drug Exposure Time: 28 daysDescription: Calculated as the number of days (mean) any persistent symptom lasted per patient as listed below. overall health, short of breath, chills, cough, diarrhea, ear pain, fatigue, fever, headache, hoarseness, muscle ache, phlegm, runny nose, sinus congestion, sneezing, sore throat, watery eyes, wheezing
Measure: Duration of Symptoms Time: from baseline up to 28 daysDescription: The number of participants with ICU admissions was evaluated.
Measure: Number of Participants With ICU Admissions Time: baseline and up to 58 daysDescription: Only 5 patients had partial pharmacokinetic (PK) data available. Plasma concentration of oseltamivir was measured at several time points in one patient receiving neuraminidase inhibitor monotherapy. Plasma concentration of oseltamivir, amantadine, and ribavirin were measured at several time points in four patients receiving TCAD therapy. Area under the time-concentration curve up to the last measured time point (AUC0-last) was calculated from the plasma concentration-time profiles by non-compartmental analysis.
Measure: Pharmacokinetics (AUC0-last) of TCAD Time: 5 days