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Completed

NCT Number: NCT01189487

The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)

Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.

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Key information

Conditions

Pneumonia, Bacterial Bacterial Infections Bacterial Infections and Mycoses Community-Acquired Infections Community-Acquired Pneumonia Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

16 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tosei General Hospital, Seto-shi, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 16 years of age or older.
  • Patients who were diagnosed as moderate to severe community acquired pneumonia requiring initial intravenous therapy and hospitalization.

Exclusion criteria

  • Known or suspected hypersensitivity or intolerance to ampicillin sodium/sulbactam sodium, other penicillins, or cephems.
  • Hepatic dysfunction [Aspartate Aminotransferase(AST), Alanine Aminotransferase (ALT), total bilirubin > 3 times upper limit of normal range values].
  • Severe renal dysfunction (creatinine clearance < 30 ml/min).
  • Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.

Treatment and study plan

ampicillin sodium/sulbactam sodium

Drug

ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days

Other names: Unasyn-S

Primary outcomes

  1. Response Rate (Clinical Response, Data Review Committee Assessment)

    Time frame: End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)

    Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.

Secondary outcomes

  1. Response Rate (Clinical Response, Investigator Assessment)

    Time frame: End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)

    Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants EXCLUDING ones assessed as indeterminate" multiplied by 100.

  2. The Tendency Toward Clinical Improvement (Investigator Assessment)

    Time frame: Day 4

    The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 4 and was determined to continue the treatment.

  3. Eradication Rate (Bacteriological Response, Data Review Committee Assessment)

    Time frame: Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)

    Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication, presumed eradication or microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment.

  4. Eradication Rate (Bacteriological Response, Investigator Assessment)

    Time frame: Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)

    Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication , presumed eradication or microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Multicenter, Unblinded, Non-Comparative Study Of Unasyn-S 12 G/Day Evaluating The Safety And Efficacy In Japanese Adult Subjects With Community Acquired Pneumonia

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 26, 2010
Registry last updated
Jul 13, 2012

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

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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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