Efficacy of Sambucol in the Treatment of Influenza
Recruitment status was: Active, not recruiting
|First Submitted Date ICMJE||September 10, 2006|
|First Posted Date ICMJE||September 12, 2006|
|Last Update Posted Date||November 6, 2007|
|Start Date ICMJE||September 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The length of time to resolution of influenza illness|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00375115 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Efficacy of Sambucol in the Treatment of Influenza|
|Official Title ICMJE||Efficacy of Sambucol on the Length of Time to Resolution of Influenza Illness|
|Brief Summary||The trial will examine the efficacy of sambucol in the treatment of influenza. The primary efficacy endpoint will be the length of time to resolution of influenza illness.The double blind trial will be conducted at the Personnel Clinic, and at the Clinical virology Unit, Hadassah University Hospital, and will include 100 patients with laboratory-confirmed influenza infection, 50 in the sambucol and 50 in the placebo study arm.|
The trial will be conducted at the Personnel Clinic, and at the Clinical virology Unit, Hadassah University Hospital.
Candidates for participation in the trial :
Patients who will present at the clinic with influenza-like symptoms; men and women ages 20 yrs- 65 yrs who will sign written informed consent
Excluded from the trial will be:
The study participants will receive treatment (either Sambucol or placebo) for five days. The follow-up period will be 10 days. All patients initially included in the trial will be followed for 10 days.
Study Patients A total of 100 patients with laboratory-confirmed influenza infection will be included in the study (50 in each study arm).
This calculation is based on the expected percentage of recovery within 3 days from initial treatment (allowing that 80% of patients given the active component will show improvement as opposed to 50% of placebo patients).
Assuming that 50% of the patients presenting with influenza-like illness will have a laboratory-confirmed influenza infection, a total number of 200 patients is expected.
The primary efficacy endpoint will be the length of time to resolution of influenza illness (defined as the period from start of study drug to the relief of symptoms).
Laboratory diagnosis of influenza infection:
Combined nose and throat specimens will be tested for the presence of influenza virus at the Clinical Virology Unit by real-time PCR, following viral RNA extraction, using the TaqMan ABI 7900 instrument. Primers and fluorescent probes specific for influenza A and B viruses will be employed in a multiplex reaction.
Specimens found positive for influenza by real-time PCR will be further subjected to influenza culture on MDCK cells.
The recovered influenza viruses will be subtyped by hemagglutination inhibition, using specific antisera obtained from the WHO, or by multiplex reverse transcription (RT)- PCR reaction, using specific primers for influenza B as well as for the different influenza A H and N.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Intervention ICMJE||Drug: Sambucol|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||100|
|Estimated Completion Date||September 2009|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||20 Years to 65 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Israel|
|Removed Location Countries|
|NCT Number ICMJE||NCT00375115|
|Other Study ID Numbers ICMJE||360HMO-CTIL|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Hadassah Medical Organization|
|Collaborators ICMJE||Razei Bar industries Ltd.|
|PRS Account||Hadassah Medical Organization|
|Verification Date||October 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP