A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with intra-abdominal infections.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
804
Moxifloxacin, 400mg, administered intravenously once daily
Active treatment: Ertapenem 1.0g, administered intravenously once daily
Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population
Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.
Time frame: 21 to 28 days after completion of study drug therapy
Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population
Clinical improvement = Reduction in the severity and/or number of signs and symptoms of infection.Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered.
Time frame: During treatment at day 5 +/- 1 day
Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s)
Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection'.
Time frame: During treatment at day 5 +/- 1 day
Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population
Clinical cure = resolution/improvement of clinical signs and symptoms related to the infection without wound infection requiring systemic antibiotic treatment. Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered.
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Unnamed facility
Ciudadela, Buenos Aires, Argentina
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De Febrero 3, Buenos Aires, Argentina
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Merlo, Buenos Aires, Argentina
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San Juan Bautista, Buenos Aires, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Mendoza, Mendoza Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Capital Federal, Argentina
Unnamed facility
Bruxelles - Brussel, Belgium
...and 42 more locations
Time frame: after 5 - 14 days of therapy
Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)
Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection'.
Time frame: After 5 - 14 days of therapy
Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)
Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection' - additionally, any recurrence or reinfection was treated as bacteriological failure at TOC.
Time frame: 21 - 28 days after end of therapy
Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s)
Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.
Time frame: 21 - 28 days after end of therapy
Number of Subjects Who Died Due to Intra-abdominal Infections
Number of subjects who had died due to intra abdominal infections by the time of TOC visit.
Time frame: 21 - 28 days after end of treatment at TOC Visit
Duration of Hospitalization
Duration of hospitalization in the per protocol population.
Time frame: From the first admission date to the discharge date (from 4 to 71 days after start of study medication)
Duration of Hospitalization Postoperatively
Duration of hospitalization after the first surgery until discharge in the per protocol population.
Time frame: Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication)