Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03137173
Other study ID # BPR-CS-008
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 19, 2018
Est. completion date April 22, 2019

Study information

Verified date May 2023
Source Basilea Pharmaceutica
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients to establish the safety and efficacy of ceftobiprole medocaril compared with vancomycin plus aztreonam in the treatment of acute bacterial skin and skin structure infections (ABSSSIs).


Description:

This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients with ABSSSIs. Randomization was stratified by study site and type of ABSSSI (with major cutaneous abscess comprising ≤ 30% of the Intent-to-Treat [ITT] population). Primary endpoint for FDA: Early clinical response based on the percent reduction in lesion size at 48-72 hours compared to baseline in patients who did not receive rescue therapy and were alive, in the ITT population. Primary endpoint for EMA: Investigator-assessed clinical success at the test-of-cure (TOC) visit 15-22 days after randomization, in the co-primary ITT and Clinically Evaluable (CE) populations.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ceftobiprole medocaril
ceftobiprole 500 mg was to be administered every 8 hours as a 2-hour IV infusion (with dose adjustment for renal impairment). The treatment duration was for a minimum of 5 days and a maximum of 10 days. Treatment could be extended up to 14 days if in the investigator's opinion this was required, and the extension was approved by the sponsor's medical monitor.
vancomycin+aztreonam
Vancomycin 1000 mg (or 15 mg/kg) was to be administered every 12 hours (with dose adjustment for renal impairment) as 2-hour IV infusion. Vancomycin dose adjustment for morbidly obese and hypermetabolic patients was to be done according to local standard of care. When locally available, vancomycin trough testing (VTT) might have been used by the unblinded pharmacist or delegate to adjust the vancomycin dose. The treatment duration was for a minimum of 5 days and a maximum of 10 days. Treatment could be extended up to 14 days if in the investigator's opinion this was required, and the extension was approved by the sponsor's medical monitor. Aztreonam 1000 mg was to be administered as a 0.5-hour IV infusion every 12 hours. If CLCR was < 30 mL/min (i.e., severe renal impairment), the aztreonam dosage regimen was to be adjusted. The requirement to continue aztreonam therapy beyond Day 3 was to be reassessed at the 72-hour study visit.

See more »

Sponsors (1)

Lead Sponsor Collaborator
Basilea Pharmaceutica

Countries where clinical trial is conducted

United States,  Bulgaria,  Hungary,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Early Clinical Response Comparison of early clinical response, including = 20% reduction from baseline in the primary lesion area (based on ruler measurements), survival for = 72 hours and no rescue therapy in the ITT population 48-72 hours after start of study drug treatment
Secondary Investigator-assessed Clinical Success in the ITT Population Comparison of investigator-assessed clinical success (based on resolution of baseline signs and symptoms of the primary infection) in the ITT population 15-22 days after randomization
Secondary Investigator-assessed Clinical Success in the Clinically Evaluable (CE) Population Comparison of investigator-assessed clinical success (based on resolution of baseline signs and symptoms of the primary infection) in the clinically evaluable (CE) population 15-22 days after randomization
See also
  Status Clinical Trial Phase
Terminated NCT01734694 - Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients Phase 4
Completed NCT02961764 - Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Phase 4
Completed NCT02570490 - Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections Phase 3
Completed NCT00949130 - Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Phase 2
Completed NCT03176134 - A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018) Phase 3
Completed NCT03405064 - Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Phase 3