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A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections

Information source: Janssen Research & Development, LLC
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Abscess, Intra-Abdominal; Abdominal Abscess; Abdomen, Acute; Abdominal Pain; Appendicitis; Rupture; Infection; Intestinal Perforation; Peritonitis; Ileus

Intervention: doripenem (Drug); meropenem placebo (Drug); meropenem (Drug); doripenem placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Janssen Research & Development, LLC

Official(s) and/or principal investigator(s):
Janssen Research & Development, LLC C. Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com

Summary

The purpose of the study is to evaluate the safety and tolerability of doripenem compared with meropenem in children hospitalized with complicated intra abdominal infections.

Clinical Details

Official title: A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Meropenem in Hospitalized Children With Complicated Intra-Abdominal Infections

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The safety of doripenem compared with meropenem in children with cIAI will be evaluated by monitoring adverse events, changes in clinical laboratory tests, and findings from vital signs measurements and physical examinations.

Secondary outcome:

Clinical cure rate and favorable per-patient microbiological response rate of doripenem compared with meropenem at test of cure (TOC) visit

Clinical improvement of doripenem compared with meropenem at end of treatment (EIV) for iv study drug therapy

Clinical cure rate and favorable per-patient microbiological response rate of doripenem compared with meropenem at late follow Up (LFU) visit

Characterize pharmacokinetics of doripenem in hospitalized children with cIAI on the basis of a sparse pharmacokinetic sampling scheme

Detailed description: This is a randomized (study drug assigned by chance), double-blind (neither physician nor patient knows the name of the assigned study drugs), double-dummy (all patients are given both a placebo [salt solution] and study drug in alternating periods of time during the study), active comparator-controlled (compare the "test" treatment to standard-of-care therapy), multinational, multicenter study to evaluate the safety of the study drugs (doripenem and meropenem) administered by intravenous (iv) infusion (slow injection of drug solution into the vein over a period of time) in children aged 3 months to less than 18 years who are hospitalized with complicated intra abdominal infections (cIAI). Complicated intra abdominal infections include but are not limited to appendicitis with rupture and/or abscess (local collection of pus), acute (severe or intense) gastric, duodenal (beginning section of the small intestine), or gall bladder perforation (a hole in the wall of the stomach, small intestine, or gallbladder), and secondary peritonitis. The study will include 3 periods: a pretreatment (screening) period that will occur within 2 days prior to randomization (assignment of study drug), a treatment period of 5 to 14 days where patients will receive iv study drug treatment only or IV study therapy and a switch to oral antibiotic therapy, and a posttreatment period consisting of 2 study visits. The max duration of study drug therapy is 14 days. The total duration of the study is approximately 7 to 8 weeks. Safety and tolerability will be evaluated by examining the incidence, severity, and type of adverse events, changes in clinical laboratory tests, vital signs measurements, and findings from physical examinations observed during treatment and at each posttreatment visit. An independent monitoring committee (IDMC) will be established for this study to ensure that the safety of patients is not compromised. The IDMC will consist of individuals who are not associated with the conduct of the study, and will include but will not be limited to individuals with expertise relevant to the care of pediatric patients, and including at least one infectious disease physician and at least one statistician. Patients will receive IV Doripenem (20 mg/kg to 500 mg/dose) and meropenem placebo OR meropenem (20 mg/kg to 1 gram/dose) and doripenem placebo once every 8 hours for up to 14 days. If the patient's cIAI symptoms improve after 72 hours of treatment with iv study drug, the investigator may choose to stop iv study drug and switch the patient to an orally administered antibiotic (amoxicillin/clavulanate postassium) to complete the 5- to 14 day course of antibiotic therapy.

Eligibility

Minimum age: 3 Months. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients who are eligible for the study must have clinical evidence of cIAI

- Require surgical intervention (eg, laparotomy, laparoscopic surgery, or percutaneous

drainage) to manage the cIAI

- Require antibacterial therapy for 5 to 14 days in addition to the surgical

intervention

- Must, based on the judgment of the investigator, require hospitalization initially

and antibacterial therapy for 5 to 14 days in addition to surgical intervention for the treatment of the current cIAI. (Note that the patient must require at least 3 days of IV antibiotic therapy initially)

- Have a signed informed consent form completed by the patient's parent or legal

representative (and a signed assent form obtained from patients who are capable of providing assent, typically, children 7 years of age and older)

Exclusion Criteria:

- Have a history of hypersensitivity reactions to carbapenems, cephalosporins,

penicillins, or other beta-lactam antibiotics

- concomitant infection including but not limited to suspected or confirmed meningitis

or central nervous system infection requiring systemic antibiotic or antifungal therapy in addition to the iv study drug therapy at the time of randomization

- Receipt of nonstudy systemic antibiotic therapy for cIAI for more than 24 hours

immediately preceding the start of the infusion of the first dose of iv study drug therapy

- Have a diagnosis of abdominal wall abscess confined to musculature of the abdominal

wall, small bowel obstruction or ischemic bowel disease without perforation, traumatic bowel perforation requiring surgery within 12 hours of perforation, or perforation of gastroduodenal ulcers requiring surgery within 24 hours of perforation (these are considered situations of peritoneal soiling before the infection has become established)

- Have simple (noncomplicated), nonperforated appendicitis or gangrenous appendicitis

without rupture into the peritoneal cavity identified during a surgical procedure OR presence of spontaneous bacterial peritonitis or peritonitis associated with cirrhosis or chronic ascites

- Known at the time of randomization to have a cIAI caused by at least one pathogen

that is nonsusceptible to doripenem or meropenem

- Presence of any of the following clinically significant laboratory abnormalities:

Hematocrit of less than 20%, absolute neutrophil count (ANC) <500 cells/µL, platelet count <40,000 cells/µL, serum alanine aminotransferase or aspartate aminotransferase (AST) or total bilirubin 5 times or greater the age-specific upper limit of normal (ULN) or acute/chronic renal insufficiency with a baseline creatinine clearance <50 mL per minute or requires dialysis therapy for any reason

- Have a history of uncontrolled epilepsy defined as at least 1 seizure within the 6

months before randomization

Locations and Contacts

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com

Buenos Aires, Argentina; Completed

Buenos Aires N/A, Argentina; Completed

Córdoba, Argentina; Withdrawn

Loma Hermosa N/A, Argentina; Recruiting

Paraná, Entre Ríos, Argentina; Completed

Santa Fe, Argentina; Completed

Belo Horizonte, Brazil; Not yet recruiting

Campinas, Brazil; Withdrawn

Caxias Do Sul, Brazil; Withdrawn

Passo Fundo, Brazil; Recruiting

São José Do Rio Preto, Brazil; Suspended

São Paulo, Brazil; Withdrawn

Santiago, Chile; Suspended

Valdivia X Región, Chile; Suspended

Armenia, Colombia; Withdrawn

Bogota, Colombia; Withdrawn

Bogotá, Colombia; Withdrawn

Cali, Colombia; Withdrawn

Cali Valle Del Cauca, Colombia; Withdrawn

Floridablanca, Colombia; Not yet recruiting

Medellin, Colombia; Withdrawn

Bangalore, India; Not yet recruiting

Ludhiana, India; Withdrawn

Mangalore, India; Withdrawn

Nagpur, India; Not yet recruiting

Pune, India; Withdrawn

Secunderabad, India; Withdrawn

Riga, Latvia; Recruiting

Kaunas, Lithuania; Recruiting

Klaipeda, Lithuania; Not yet recruiting

Vilnius, Lithuania; Recruiting

Zona, Panama; Recruiting

Oakland, California, United States; Withdrawn

San Diego, California, United States; Recruiting

Aurora, Colorado, United States; Withdrawn

Washington, District of Columbia, United States; Recruiting

Chicago, Illinois, United States; Withdrawn

Louiseville, Kentucky, United States; Withdrawn

New Orleans, Louisiana, United States; Withdrawn

Boston, Massachusetts, United States; Withdrawn

Royal Oak, Michigan, United States; Withdrawn

New York, New York, United States; Withdrawn

Akron, Ohio, United States; Withdrawn

Cleveland, Ohio, United States; Recruiting

Toledo, Ohio, United States; Recruiting

Pittsburgh, Pennsylvania, United States; Withdrawn

Additional Information

To learn how to participate in this trial please click here.

Starting date: December 2010
Last updated: January 17, 2013

Page last updated: February 07, 2013

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