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Efficacy Study of Early Versus Late Oseltamivir Administration for Treating and Preventing Influenza

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Edward Belongia, Marshfield Clinic Research Foundation
ClinicalTrials.gov Identifier:
NCT00555893
First received: November 7, 2007
Last updated: January 13, 2015
Last verified: January 2015
Results First Received: January 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Influenza
Interventions: Drug: Oseltamivir
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant in the 194 enrolled was negative for influenza by polymerase chain reaction at randomization and was therefore excluded leaving 193 individuals started in the study.

Reporting Groups
  Description
Active Drug

Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:

for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)

Placebo

Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.

Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.


Participant Flow:   Overall Study
    Active Drug   Placebo
STARTED   130   63 
Final Analysis   114 [1]   51 [2] 
COMPLETED   130   63 
NOT COMPLETED   0   0 
[1] n=16 excluded from number started because >119 hrs
[2] n=12 excluded from number started because >119 hrs



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Active Drug

Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:

for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)

Placebo

Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.

Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.

Total Total of all reporting groups

Baseline Measures
   Active Drug   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 114   51   165 
Age, Customized 
[Units: Years]
     
<2 years   4   1   5 
2-18 years   54   28   82 
>18 years   56   22   78 
Gender 
[Units: Participants]
     
Female   65   34   99 
Male   49   17   66 
Region of Enrollment 
[Units: Participants]
     
United States   114   51   165 
Influenza Type [1] 
[Units: Participants]
     
Type A   85   38   123 
Type B   28   13   41 
[1] Number of individuals positive by polymerase chain reaction (PCR) assay by flu type; 1 excluded who was positive for both A & B


  Outcome Measures
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1.  Primary:   Duration of Influenza Illness   [ Time Frame: Interval (in 12 hour blocks) from time of randomization until resolution (minimum 7 days, maximum 14 days) ]

2.  Secondary:   Mean Illness Severity Score   [ Time Frame: Calculated from initial enrollment (randomization) up to first period of symptom resolution (minimum of 7 days, maximum of 14 days) ]

3.  Secondary:   Duration of Viral Shedding   [ Time Frame: Interval (in days) from collection of the first sample yielding a positive influenza test to the last sample yielding a positive culture (maximum 14 days) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Secondary Complications (New Clinical Diagnosis of Acute Otitis Media, Acute Sinusitis or Radiographically Confirmed Pneumonia)Documented in Medical Record, or Influenza-related Hospital Admission   [ Time Frame: From 0 to 30 days after randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Mean Influenza Well-being Score (Health, Ability to Perform Usual Activities and Sleep Quality)   [ Time Frame: Interval from randomization up to and including first day of symptom resolution (minimum 7 days, maximum 14 days) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Edward Belongia, MD
Organization: Marshfield Clinic Research Foundation
phone: 715-389-3783
e-mail: belongia.edward@mcrf.mfldclin.edu



Responsible Party: Edward Belongia, Marshfield Clinic Research Foundation
ClinicalTrials.gov Identifier: NCT00555893     History of Changes
Other Study ID Numbers: 1U01IP000124-01 ( US NIH Grant/Contract Award Number )
Study First Received: November 7, 2007
Results First Received: January 7, 2015
Last Updated: January 13, 2015
Health Authority: United States: Institutional Review Board