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Report for Clinical Trial NCT00867139

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Pilot, Randomized Study Comparing the Safety, Tolerability and Pharmacokinetics of Combination Therapy (Amantadine, Ribavirin, Oseltamivir) Versus Neuraminidase Inhibitor Monotherapy to Influenza Virus Infected Immunocompromised Patients

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

NCT00867139 Influenza
MeSH:Influenza, Human

3 Interventions

Name: TCAD

Description: TCAD (amantadine hydrocholoride, ribavirin and oseltamivir phosphate)
Type: Drug
Group Labels: 1

TCAD-Randomized Arm

Name: Zanamivir or Oseltamivir

Description: Zanamivir or Oseltamivir
Type: Drug
Group Labels: 1

Neuraminidase Monotherapy Arm

Name: Open label treatment with TCAD

Description: TCAD(amantadine hydrocholoride, ribavirin and oseltamivir phosphate)
Type: Other
Group Labels: 1

TCAD Open Label Arm

Primary Outcomes

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 drug

Secondary Outcomes

Description: 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 days

Measure: Number of Patients Not Shedding Virus at Day 5 +/-1 and Day 10 +/- 1

Time: 10 days

Description: 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 days

Description: 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 days

Measure: Frequency of Confirmed Pneumonia

Time: 58 days

Measure: Duration of Hospitalization

Time: from baseline up to 58 days

Measure: Days on Supplemental Oxygen

Time: 58 days

Description: The number of participants with ICU admissions was evaluated.

Measure: Number of Participants With ICU Admissions

Time: baseline and up to 58 days

Measure: Number of Participants With Intubations

Time: 58 days

Measure: Number of Deaths

Time: 58 days

Description: 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

Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP


1 H274Y

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 ---

HPO Nodes