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Trial record 32 of 212 for:    Louisville AND placement

Rapid Empiric Treatment With Oseltamivir Study (RETOS) (RETOS)

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ClinicalTrials.gov Identifier: NCT01248715
Recruitment Status : Completed
First Posted : November 25, 2010
Results First Posted : September 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Julio Ramirez, University of Louisville

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Influenza
Pneumonia
Intervention: Drug: oseltamivir

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Oseltamirvir

These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.

oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability

Standard of Care These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record.

Participant Flow:   Overall Study
    Oseltamirvir   Standard of Care
STARTED   556   551 
COMPLETED   55   41 
NOT COMPLETED   501   510 
Not influenza positive                501                510 



  Baseline Characteristics

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
Oseltamirvir

These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.

oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability

Standard of Care These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record.
Total Total of all reporting groups

Baseline Measures
   Oseltamirvir   Standard of Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 55   41   96 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 63 
 (41.5 to 84.5) 
 60 
 (43 to 77) 
 61.7 
 (42.1 to 81.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      23  41.8%      23  56.1%      46  47.9% 
Male      32  58.2%      18  43.9%      50  52.1% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   55   41   96 
Nursing home Resident 
[Units: Participants]
Count of Participants
 0   2   2 


  Outcome Measures

1.  Primary:   Number of Participants With Clinical Failure (Failure to Reach Clinical Stability)   [ Time Frame: 7 days ]

2.  Primary:   Number of Participants to Transfer to ICU After 24 h   [ Time Frame: 24 h ]

3.  Primary:   Number of Participants That Required Re-hospitalization   [ Time Frame: 30 days ]

4.  Primary:   Number of Participants That Had Short-term Mortality   [ Time Frame: 30 days ]

5.  Secondary:   Days to Reach Clinical Stability   [ Time Frame: 30 days ]

6.  Secondary:   Length of Hospital Stay   [ Time Frame: through study completion, up to 30 days ]

7.  Secondary:   Number of Participants With Hospital Mortality.   [ Time Frame: through study completion, up to 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
The primary limitation of our study that we were not able to reach the number of patients that were estimated in the sample size calculation.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Paula Peyrani
Organization: University Louisville
phone: 502-852-3905
e-mail: paula.peyrani@louisville.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Julio Ramirez, University of Louisville
ClinicalTrials.gov Identifier: NCT01248715     History of Changes
Other Study ID Numbers: RETOS
First Submitted: November 23, 2010
First Posted: November 25, 2010
Results First Submitted: August 7, 2017
Results First Posted: September 6, 2017
Last Update Posted: November 6, 2017