A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis... | NCT00412555

Studies
A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.

NCT00412555

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Aug 18, 2020Actual

Enrollment

52Actual

Phase

Phase 4

Conditions

Influenza

Interventions

oseltamivir [Tamiflu]

Countries

United States
Canada
Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Dec 15, 2006

First Submission Date that Met QC Criteria

Dec 15, 2006

First Posted Date

Dec 18, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2020

Last Update Posted Date

Aug 18, 2020Actual

Description Module

Brief Summary

This study will evaluate the safety of Tamiflu, when used for the prevention of influenza in children during the flu season. Children who would benefit from influenza prophylaxis when influenza is circulating in the community will receive treatment with Tamiflu syrup (or capsules) 30mg-75mg once daily (dependent on body weight) for 6 weeks. Safety data and influenza symptoms will be recorded throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: oseltamivir [Tamiflu]

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oseltamivir [Tamiflu]	Drug	30-75mg po daily for 6 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AEs, laboratory parameters, vital signs.		Throughout study
Percentage of patients with laboratory confirmed clinical influenza		Throughout study

Secondary Outcomes

Measure	Description	Time Frame
Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness.		Throughout study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

males or females, 1-12 years of age;
candidate for seasonal prophylaxis;
negative rapid diagnostic test for influenza at baseline.

Exclusion Criteria:

symptoms suggestive of influenza-like illness;
positive rapid diagnostic test for influenza;
antiviral treatment for influenza in 2 weeks prior to randomization.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		West Palm Beach	Florida	33409	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22520945	Derived	Reisinger K, Shu D, Cupelli L, Marcadis I, Dutkowski R. Safety and tolerability of a 6-week course of oseltamivir prophylaxis for seasonal influenza in children. Influenza Other Respir Viruses. 2013 Jan;7(1):11-3. doi: 10.1111/j.1750-2659.2012.00367.x. Epub 2012 Apr 23.

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D053138	Cyclohexenes
D003510