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Prospective, multicenter, double-blind, randomized study to evaluate the safety and efficacy of BAY 12-8039 (moxifioxacin) 400 mg administered sequentially (intravenously / orally) every 24 hours compared with piperacillin / tazobactam 3.375 grams intravenously every 6 hours, followed of oral suspension of amoxicillin / clavulanic acid 800 mg every 12 hours for the treatment of patients with complicated skin and soft tissue infections.

Prospective, multicenter, double-blind, randomized study to evaluate the safety and efficacy of BAY 12-8039 (moxifioxacin) 400 mg administered sequentially (intravenously / orally) every 24 hours compared with piperacillin / tazobactam 3.375 grams intravenously every 6 hours, followed of oral suspension of amoxicillin / clavulanic acid 800 mg every 12 hours for the treatment of patients with complicated skin and soft tissue infections.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-001-03
Enrollment
Unknown
Registered
2003-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Moxifloxacin 400/400 mg Type of group
Moxifloxacin 400 mg will be administered by intravenous infusion for 60 minutes every 24 hours (plus a placebo infusion of piperacillin / tazobactam every 6 hours). If the patient is changed intravenous treatment to oral tablet of moxifloxacin 400 mg every 24 hours, you will also receive placebo suspension of amoxicillin-clavulanic acid every 12 hours. Group name:Piperacillin / tazobactam 3.0 / 0.375 g Type of group
Piperacillin / tazobactam 3.0 / 0.375 g will be administered by intravenous infusion for 60 minutes every 6 hours (plus a placebo infusion of moxifloxacin every 24 hours). If the treatment is changed from intravenous piperacillin / tazobactam to oral suspension of amoxicillin / clavulanic acid 800 mg every 12 hours, the patient will also receive a placebo tablet of moxifloxacin every 24 hours.

Sponsors

BAYER S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male or female inpatients> 18 years of age. Women Potentially fertile should have a negative pregnancy test and sexually active women should use an acceptable contraceptive method (hormonal or barrier) while the treatment lasts. Diagnosis of skin and soft tissue infections that can be confirmed or suspected based on a Gram stain. The duration of treatment of skin / soft tissue infection will be at least 7 days

Exclusion criteria

Exclusion criteria: Patients with uncomplicated skin and soft tissue infections that do not require hospitalization or initial treatment with intravenous antibiotics. Known hypersensitivity to any of the study medications including penicillins and cephalosporins. History of hypersensitivity to multivitamin concentrates for infusion or preexisting hypervitaminosis. Background of phenylketonuria. Pregnant women, breastfeeding or in which pregnancy can not be excluded. Renal insufficiency.

Design outcomes

Primary

MeasureTime frame
Outcome name:The clinical response to the therapy will be based on serial examinations of the patient to determine the effect of the therapy on the signs and symptoms of the infection. Measure:Efficacy of 2 sequential treatment regimens for the treatment of adult patients with complicated skin and soft tissue infections. Timepoints:14 days—

Secondary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated—

Countries

Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)