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NCT Number: NCT00412737

A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants

This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Negative rapid diagnostic test for influenza at baseline;
  • Immunocompromised participant (liver and/or kidney recipient or allogenic hematopoietic stem cell transplant).

Exclusion criteria

  • Symptoms suggestive of influenza-like illness; but not limited to fever, cough, or nasal congestion;
  • Influenza vaccination in 6 weeks prior to randomization;
  • Positive rapid diagnostic test for influenza;
  • Solid organ transplant within 6 months of randomization;
  • Antiviral treatment for influenza in 2 weeks prior to randomization.

Treatment and study plan

oseltamivir

Drug

Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.

Other names: Tamiflu

Placebo

Drug

Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.

Primary outcomes

  1. Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population

    Time frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)

    Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than [>] 37.2 degrees Celsius [°C]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum hemagglutination inhibition (HAI) titers measured from baseline to any point during the study.

Secondary outcomes

  1. Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population

    Time frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)

    Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.

  2. Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population

    Time frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)

    Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.

  3. Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population

    Time frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)

    RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.

  4. Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population

    Time frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)

    RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.

  5. Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population

    Time frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)

    RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.

  6. Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population

    Time frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)

    RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 18, 2006
Registry last updated
Jun 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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