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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR UNASYN

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Clinical Trials for Unasyn

Trial ID Title Status Sponsor Phase Summary
NCT00760006 Preoperative Antibiotics Study Completed Children's Hospital of Pittsburgh Phase 2 The primary objective of this study is to determine the efficacy of administering a single dose of preoperative antibiotics to prevent complications in patients undergoing primary closure of a cleft secondary palate. Secondary objective of this study is to evaluate the effects of preoperative antibiotics administered on post operative outcome following primary closure of cleft secondary palate. The study aims to assess the efficacy of prophylactic antibiotics in cleft surgery to - decrease the incidence of surgical sight infections - speed the progression of postoperative healing - improve the final quality of wound healing achieved - decrease the rate of palatal fistula formation
NCT00879190 Comparison of Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Intrapartum Chorioamnionitis: a Randomized Controlled Trial Active, not recruiting Stanford University Phase 2/Phase 3 Chorioamnionitis is an infection of the placenta and amniotic membranes (bag of waters) surrounding the baby inside of a pregnant woman prior to delivery. This infection is somewhat common and is routinely treated with antibiotics given to the mother both before and after the baby is born. Currently it is not known what is the best choice of antibiotics to treat this type of infection, but commonly used treatments include Unasyn (ampicillin/sulbactam) or ampicillin/gentamicin. We plan to compare these two different antibiotic regimens to see if one is better than the other at treating and preventing bad outcomes from chorioamnionitis in women and babies.
NCT01118403 Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients Withdrawn Hospital Pablo Tobón Uribe Phase 4 This study seeks to assess whether coma patients really benefit from the use of antibiotics as a prophylactic for reducing the incidence of early ventilator-associated pneumonia in this population group. For this we consider the use of ampicillin sulbactam antibiotic which has a low ability to induce resistance, efficacy and safety observed during the time that has been used, even in patients with neurosurgical pathology, and to be broadly available in our environment. Our hypothesis is that neurological patients in coma state, requiring mechanical ventilation, the application of antibiotic prophylaxis compared with placebo reduces the incidence of early ventilator-associated pneumonia.
NCT01189487 The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP) Completed Pfizer Phase 3 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.
NCT01793688 Drug Use Investigation Of Sulbactam/Ampicillin (UNASYN) 12g (Regulatory Post Marketing Commitment Plan) Completed Pfizer N/A The purpose of the survey is to study the followings under practical use, regarding the safety and effectiveness in high-dose administration (exceeding 6 g per day) of UNASYN-S and UNASYN-S KIT for intravenous use (UNASYN). 1. Adverse Drug Reaction(s) that cannot be expected from precautions (Unexpected Adverse Drug Reaction) 2. Incidence status of adverse drug reactions 3. Factors that may affect the safety and effectiveness
NCT03560232 Noninferiority Comparison of Prophylactic Open Fracture Antimicrobial Regimens Recruiting Mercy Health Ohio Phase 4 To demonstrate noninferiority of three different empiric antimicrobial regimens compared to the traditional antimicrobial regimen for the management of grade III open fractures as well as evaluate outcomes among these groups.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Unasyn

Condition Name

Condition Name for Unasyn
Intervention Trials
Chorioamnionitis 1
Pneumonia, Bacterial 1
Pneumonia 1
Peritonitis 1
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Condition MeSH

Condition MeSH for Unasyn
Intervention Trials
Pneumonia 3
Lung Abscess 1
Pneumonia, Bacterial 1
Wound Infection 1
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Clinical Trial Locations for Unasyn

Trials by Country

Trials by Country for Unasyn
Location Trials
Japan 15
United States 3
Colombia 1
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Trials by US State

Trials by US State for Unasyn
Location Trials
Ohio 1
California 1
Pennsylvania 1
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Clinical Trial Progress for Unasyn

Clinical Trial Phase

Clinical Trial Phase for Unasyn
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Unasyn
Clinical Trial Phase Trials
Completed 3
Active, not recruiting 1
Recruiting 1
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Clinical Trial Sponsors for Unasyn

Sponsor Name

Sponsor Name for Unasyn
Sponsor Trials
Pfizer 2
Mercy Health Ohio 1
Hospital Pablo Tobón Uribe 1
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Sponsor Type

Sponsor Type for Unasyn
Sponsor Trials
Other 4
Industry 2
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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fuji
Deloitte
US Army
Chinese Patent Office
Cipla
Federal Trade Commission
Harvard Business School
Covington

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