Clinical Trials Logo
  1. Home
  2. Pneumonia
  3. NCT01793688
  4. Details
NCT01793688 Clinical Trial

Drug Use Investigation Of Sulbactam/Ampicillin (UNASYN) 12g (Regulatory Post Marketing Commitment Plan)

Pneumonia Clinical Trial

Official title:
Drug Use Investigation Of Sulbactam/Ampicillin 12g

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01793688
Other study ID # A9231002
Secondary ID
Status Completed
Phase N/A
First received February 4, 2013
Last updated December 7, 2015
Start date March 2013
Est. completion date September 2015

Study information
Verified date December 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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

Description:

Implemented as a Special Investigation by a central registration system

Recruitment information / eligibility
Status Completed
Enrollment 986
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 99 Years
Eligibility Inclusion Criteria:

- Patients with the following disease who received high doses of UNASYN (exceeding 6 g per day) from the first dosing date or the second dosing date. 1) Pneumonia, 2) Lung Abscess, 3) Peritonitis

- Patients aged 15 years or olde

Exclusion Criteria:

- Patients with the following disease who received high doses of UNASYN (less than 6 g per day) from the first dosing date or the second dosing date. 1) Pneumonia, 2) Lung Abscess, 3) Peritonitis

- Patients aged less than 15 years.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Sulbactam Sodium (SBT)/Ampicillin Sodium (ABPC)
Intravenous use; The usual adult dosage is 6 g of sulbactam sodium and ampicillin sodium (potency) per day given in two divided doses via intravenous injection or drip infusion. In the case of severe infection, the dosage may be increased if appropriate. Maximum dosage should not exceed 3 g (potency) 4 times daily (daily dose of 12 g (potency)). Kit for intravenous use; The usual adult dosage is 6 g of sulbactam sodium and ampicillin sodium (potency) per day given in two divided doses via intravenous injection after dissolved in an accompanying reconstitution diluent. In the case of severe infection, the dosage may be increased if appropriate. Maximum dosage should not exceed 3 g (potency) 4 times daily (daily dose of 12 g (potency)).

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Clinical Benefit 14 days No
Secondary C-Reactive Protein (CRP) 14 days No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04244474 - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children Phase 1/Phase 2
Completed NCT05815264 - Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above Phase 1
Recruiting NCT04589936 - Prone Position to Improve Oxygenation in COVID-19 Patients Outside Critical Care N/A
Completed NCT02905383 - The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital N/A
Completed NCT06210737 - A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years Phase 4
Terminated NCT03944551 - Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa N/A
Terminated NCT04660084 - Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT05702788 - Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19) Phase 2
Not yet recruiting NCT04171674 - Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation. N/A
Active, not recruiting NCT03140163 - Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR] N/A
Completed NCT02638649 - Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Completed NCT02864420 - Hospitalization at Home: The Acute Care Home Hospital Program for Adults N/A
Recruiting NCT02515565 - Physiotherapy in Patients Hospitalized Due to Pneumonia. N/A
Completed NCT02105298 - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study) N/A
Completed NCT01399723 - Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia Phase 3
Completed NCT01446926 - Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants Phase 1
Completed NCT01416519 - Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation N/A
Terminated NCT02358642 - Drug to Prevent Pneumonia in the Tube Fed Phase 4
Completed NCT01416506 - Community-Acquired Pneumonia (CAP) Surveillance N/A

External Links