A Prospective, Multicenter, Double-Blind, Randomized Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of MK-0826 vs. Piperacillin/Tazobactam in the Treatment of Acute Pelvic Infection in Hospitalized Wome

Not Applicable

• Conditions: -N739 Female pelvic inflammatory disease, unspecified; Female pelvic inflammatory disease, unspecified; N739

• Registration Number: PER-034-99
• Lead Sponsor: MERCK SHARP & DOHME PERÚ S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1999-01-01
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

a. One of the following:
1) Oral temperature >38°C (100.4°F),
2) WBC >10,500/nmi3, or
3) WBC differential indicating >10% immature granulocytes (band forms)
b. and at least one of the following:
1) Pelvic, abdominal, or uterine pain, or cramping.
2) Pelvic, abdominal, or uterine tenderness.
3) Sonograhic or other imaging study that suggests pelvic abscess or infection.
c. Patient has had a vaginal delivery, cesarean section, or gynecologic surgery 4 hours and within 1 month prior to enrollment. (Patients who have signs or symptoms of acute pelvic infection in l.b. within the first 24 hours following any of the above procedures may be enrolled if their temperature has been at least 101.5°F [38.6°C] in this time period). Although it is anticipated that most patients will be enrolled postoperatively or postpartum. patients who present with a well documented (radiologically or surgically confirmed) pelvic infection without a recent history of gynecologic surgery or delivery (for example, in association with appendicitis or diverticulitis) will be permitted, and will be grouped with the postoperative infections.
d. Patients with a diagnosis of septic abortion will be allowed to enroll if the severity of their illness requires a minimum of 3 full days of parenteral IV therapy. These patients will be grouped with the postoperative infections. No more than 15% of those enrolled should have a diagnosis of septic abortion.
e. Specimens from the endometrium or other infected site are taken within 48 hours of enrollment into the study and prior to administration of study antibiotic using a method to avoid contamination (e.g., Unimar Pipelle™) are sent for culture and susceptibility testing.
f. Infection is caused or presumed to be caused by microorganisms susceptible to the intravenous study antibiotics (MK-0826 and piperacillin/tazobactam).
g. Patient is female >16 years of age.
h. Females of childbearing potential must have a negative serum pregnancy test (P-HCG) prior to enroilment into the study (or must have just delivered) and, subsequently, for at least 1 month following study treatment use adequate birth control measures as discussed with the investigator. Hormonal contraceptives should not be used as the sole method of birth control, because the effect of MK-0826 on the efficacy of hormonal contraceptives has not yet been established.
i. Nursing women may participate if they agree to defer breast feeding until 5 days after completion of therapy to allow elimination of the drug from breast milk.
j. The patient´s infection is expected to require at least 3 full days of antibiotic

Exclusion Criteria

a. Failure to meet all inclusion criteria.
b. Patients with a diagnosis of pelvic inflammatory disease, tubo-ovarian abscess, or postoperative abdominal wall infection.
c. Patients known at study entry to have pelvic infections that are caused by pathogens resistant to the study antimicrobial agents
d. History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to piperacillin/tazobactam, other carbapenem antibiotics (such as imipenem), any penicillins or other p-lactam agents. Patients with history of
mild rash to penicillins or other b-lactams may be enrolled.
e. Patients who are considered unlikely to survive the study period.
f. Patients in whom a response to antibiotic therapy is considered unlikely.
g. Pregnant women, nursing women, or fertile women not practicing adequate methods of contraception; women planning to become pregnant within 1 month of the study. (Women who choose to defer breast-feeding until 5 days after the last dose of study drug to allow elimination of drug from breast milk will be eligible.)
h. The need for concomitant systemic antimicrobials (other than vancomycin or antifungal agents) in addition to those designated in the two study groups (for use of vancomycin, and antifungal therapy,
i. Patients with active gynecologic malignancy are excluded, unless the tumor has been adequately resected by surgery. However, patients who are receiving chemotherapy or radiation therapy are excluded.
j. Concurrent infection that would interfere with evaluation of response to the study antibiotic.
k. Presence of renal or hepatic disease:
1) Serum creatinine >2.0 x the upper limit of normal (Ul-N) values used by the laboratory performing the test for patients <65 years of age, and >1.5 times ULN used by the laboratory performing the test for patients >65 years of age.
Note: For patients with volume depletion and elevated creatinine, this test can be repeated after volume replacement during the screening period. If the serum creatinine value is within the specified limits before study entry, the patient will be eligible. When data from a clinical study of pharmacokinetics of MK-0826 in renal failure become available, it may be possible to enroll patients with renal insufficiency of greater degree, provided they do not require dialysis, with adjustment of dose as necessary.
2) Liver function tests:
a) ALT, AST >6 times ULN values used by the laboratory performing the test. Patients with elevations of AST and/or ALT up to 10 times ULN will be allowed if these elevations are acute and directly related to the infectious process being treated. This should be documented.
b) Bilirrubin >3.0 times ULN, unless isolated hyperbilirubinemia is directly related to the acute infection.
c) Alkaline phosphatase >3.0 times ULN. Patients with valúes
>3.0 times ULN and up to 5.0 times ULN will be eligible if this value is historically stable.
3) Patients with acute hepatic failure or acute decompensation of chronic hepatic failure should be excluded.
1. Hematocrit <25% or hemoglobin <8 g/dL.
m. Neutropenia with absolute neutrophilcount(ANC)<1000/mm3. Patients with neutrophil counts as low as 500 cells/mm3 will be permitted if this reduction is due to the acute infectious process.
n. Platelet count <75,000/mm3. Patients with platelet counts as low as 50,000 cells/mm3 will be permitted if this reduction

Study & Design

• Study Type: Interventional
• Study Design: Not specified