Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375115
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2006-09-10
Brief Title:
Efficacy of Sambucol in the Treatment of Influenza
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Efficacy of Sambucol on the Length of Time to Resolution of Influenza Illness
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 illnessThe 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
Detailed Description:
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
Pregnant women or women who cannot exclude pregnancy
Patients with diabetes
Immune-suppressed patients including patients taking immunosuppressive drugs
Patients with renal failure
Patients who received the recent influenza vaccine
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
Inclusion criteria
Fever 380C
The presence of at least one of the following respiratory symptoms cough sore throat nasal congestion runny nose
The presence of at least one of the following systemic symptoms headache fatigue myalgia chillssweats malaise
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
Study design
1 Patients presenting at the clinic with the above indicated inclusion criteria will be referred by the clinic nurse to a physician to establish the diagnosis
2 The temperature the presence and severity of influenza symptoms including cough nasal obstruction sore throat fatigue headache myalgia will be recorded on a four-point scale 0-absent 1-mild 2-moderate 3-severe Patients will also record their ability to do their normal activities overall health status and sleep quality on a ten-point scale 0-unable or worst to 10-fully able best
3 For influenza detection nose and throat swabs will be collected at baseline
4 Patients will be randomly assigned to receive either Sambucol or placebo 15 cc 4 times daily for 5 days
5 Patients will be instructed that relief medications Acamol Optalgin will be taken only as required and that their use should be recorded
6 The follow-up will include all the parameters see 2 recorded daily at days 1-5 at day 7 and at day 10
7 Compliance with the study drug will be recorded
8 In case the patients condition deteriorates the patient will be examined at the clinic to rule out the presence of complications such as pneumonia sinusitis or bronchitis
9 Statistical analysis will include the duration and severity of the symptoms as well as the use of relief medications
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
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
Pregnant women or women who cannot exclude pregnancy
Patients with diabetes
Immune-suppressed patients including patients taking immunosuppressive drugs
Patients with renal failure
Patients who received the recent influenza vaccine
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
Inclusion criteria
Fever 380C
The presence of at least one of the following respiratory symptoms cough sore throat nasal congestion runny nose
The presence of at least one of the following systemic symptoms headache fatigue myalgia chillssweats malaise
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
Study design
1 Patients presenting at the clinic with the above indicated inclusion criteria will be referred by the clinic nurse to a physician to establish the diagnosis
2 The temperature the presence and severity of influenza symptoms including cough nasal obstruction sore throat fatigue headache myalgia will be recorded on a four-point scale 0-absent 1-mild 2-moderate 3-severe Patients will also record their ability to do their normal activities overall health status and sleep quality on a ten-point scale 0-unable or worst to 10-fully able best
3 For influenza detection nose and throat swabs will be collected at baseline
4 Patients will be randomly assigned to receive either Sambucol or placebo 15 cc 4 times daily for 5 days
5 Patients will be instructed that relief medications Acamol Optalgin will be taken only as required and that their use should be recorded
6 The follow-up will include all the parameters see 2 recorded daily at days 1-5 at day 7 and at day 10
7 Compliance with the study drug will be recorded
8 In case the patients condition deteriorates the patient will be examined at the clinic to rule out the presence of complications such as pneumonia sinusitis or bronchitis
9 Statistical analysis will include the duration and severity of the symptoms as well as the use of relief medications
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None