Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection

Condition(s) targeted: Intraabdominal Infections

Intervention: Moxifloxacin (Avelox, BAY12-8039) (Drug); Ertapenem, Amoxicillin/clavulanate (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

The primary focus of the study is the evaluation of the safety of treatment with moxifloxacin in a pediatric population 3 months to <18 years old. Approximately 450 pediatric subjects with a complicated intra-abdominal infection will be enrolled in the study and treated with either moxifloxacin intravenously and orally if switched to oral therapy or ertapenem (intravenously) and, if switched to oral therapy, amoxicillin/clavulanate.

Official title: A Randomized, Double-blind, Multicenter Trial to Evaluate the Safety and Efficacy of Sequential (Intravenous, Oral) Moxifloxacin Versus Comparator in Pediatric Subjects With Complicated Intra-abdominal Infection

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

Primary outcome: Primary objective of the trial is to evaluate the safety of treatment with moxifloxacin with a special focus on cardiac and musculoskeletal events.

Secondary outcome:

Evaluation of musculoskeletal adverse events

Evaluation of electrocardiogram profiles obtained on Day 1 and Day 3 pre-treatment and post-treatment

Evaluation of clinical response at the Test-of-cure visit among subjects with a bacteriologically confirmed complicated intra-abdominal infection

Evaluation of clinical and bacteriological response to treatment at a "during therapy" visit (Day 3-5)

Evaluation of clinical and bacteriological response to treatment at the End of Treatment visit

Evaluation of clinical and bacteriological response to treatment at the Test-of-cure visit

Minimum age: 3 Months. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Hospitalized males or females 3 months to 17 years of age

- Able to obtain parental or legal guardian written informed consent and assent from

subjects as applicable by local laws and regulations

- Expected duration of treatment with antibiotics is a minimum of 3 days administered

IV, for a total of 5 to 14 days administered IV or IV followed by PO

- If the subject is a female of child-bearing potential she must have a negative

pregnancy test at the screening visit or be capable of practicing an adequate method of contraception, and agree to continue the same method for 1 month following the TOC visit. Lactating subjects are not to be included.

- Subjects may be enrolled upon a surgically (laparotomy, laparoscopy, or percutaneous

drainage) confirmed cIAI revealing at least one of the following:

- Gross peritoneal inflammation with purulent exudate within the abdominal cavity

- Intra-abdominal abscess

- Macroscopic intestinal perforation with diffuse peritonitis OR

- Subjects may be enrolled on the basis of a suspected cIAI, which must be supported

with radiological evidence (ultrasound, abdominal plain films, computed tomography [CT], magnetic resonance imaging [MRI]) of gastrointestinal perforation or localized collections of potentially infected material and at least one of the following:

- Symptoms referable to the abdominal cavity (eg, anorexia, nausea, vomiting or

pain)

- Tenderness (with or without rebound), involuntary guarding, absent or diminished

bowel sounds, or abdominal wall rigidity

- Fever

- Leukocytosis

- The subject must be scheduled for a surgical procedure (laparotomy or laparoscopy) or

percutaneous drainage.

Exclusion Criteria:

- Presumed spontaneous bacterial peritonitis

- All pancreatic processes including pancreatic sepsis, peripancreatic sepsis, or an

cIAI secondary to pancreatitis

- Early acute or suppurative (nonperforated) appendicitis unless there is evidence of

an abscess or peritoneal fluid containing pus and micro-organisms suggestive of regional contamination

- Infections originating from the female genital tract

- Known severe immunosuppression. Subjects with known mild immunosuppression (eg, Type

I or II diabetes mellitus, trauma, or absolute neutrophil count [ANC] between 1000 and 1500 cells/mm3) may be enrolled.

- Congenital or documented acquired QT prolongation

- Receiving concomitant treatment with QT prolonging drugs

- History of tendon disease/disorder related to quinolone treatment

- Pathogenic organisms suspected or identified (eg, Pseudomonas) which are resistant to

any of the study drugs

- Abnormal musculoskeletal findings at baseline assessment; or chronic musculoskeletal

disease (eg, juvenile rheumatoid arthritis); or chronic illness with high risk for chronic or recurrent arthritis or tendinitis (eg, cystic fibrosis, chronic inflammatory bowel disease)

- History of myasthenia gravis

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Córdoba 5000, Argentina; Terminated

Genk 3600, Belgium; Terminated

Gent 9000, Belgium; Terminated

Leuven 3000, Belgium; Terminated

Pleven 5800, Bulgaria; Recruiting

Plovdiv 4002, Bulgaria; Recruiting

Russe 7002, Bulgaria; Completed

Sofia 1606, Bulgaria; Recruiting

Stara Zagora 6000, Bulgaria; Recruiting

Santiago 8360160, Chile; Terminated

Santiago, Chile; Recruiting

Temuco 4781173, Chile; Terminated

Olomouc 77520, Czech Republic; Recruiting

Prague 150 06, Czech Republic; Recruiting

Athens 115 27, Greece; Recruiting

Athens 115 27, Greece; Not yet recruiting

Budapest 1086, Hungary; Recruiting

Gyor 9024, Hungary; Recruiting

Miskolc 3501, Hungary; Not yet recruiting

Bangalore 560001, India; Terminated

Daugavpils LV-5417, Latvia; Recruiting

Rezekne LV-4601, Latvia; Recruiting

Riga LV1004, Latvia; Recruiting

Kaunas LT-50009, Lithuania; Recruiting

Vilnius LT-08661, Lithuania; Recruiting

México, D.F. 04530, Mexico; Recruiting

Cusco, Peru; Recruiting

Lima LIMA 1, Peru; Recruiting

Lima, Peru; Recruiting

Lima 31, Peru; Terminated

Bucharest 41451, Romania; Terminated

Cluj Napoca 400370, Romania; Not yet recruiting

Constanta 900591, Romania; Not yet recruiting

Iasi 700309, Romania; Recruiting

Targu Mures 540136, Romania; Terminated

Timisoara 300011, Romania; Recruiting

Chelyabinsk 454076, Russian Federation; Terminated

Izhevsk 426034, Russian Federation; Terminated

Kaluga 248007, Russian Federation; Terminated

Kazan 420012, Russian Federation; Not yet recruiting

Moscow 105077, Russian Federation; Terminated

Moscow 119415, Russian Federation; Not yet recruiting

Moscow 115280, Russian Federation; Not yet recruiting

Rostov-on-Don 344091, Russian Federation; Terminated

Smolensk 214019, Russian Federation; Recruiting

Vladikaykaz 362007, Russian Federation; Not yet recruiting

Belgrade 11000, Serbia; Terminated

Nis 18000, Serbia; Terminated

Madrid 28046, Spain; Terminated

Madrid 28041, Spain; Terminated

Madrid 28009, Spain; Terminated

Dnipropetrovsk 49100, Ukraine; Recruiting

Donetsk 83052, Ukraine; Not yet recruiting

Ivano-Frankovsk 76006, Ukraine; Recruiting

Lviv 79004, Ukraine; Recruiting

Simferopol 95034, Ukraine; Recruiting

Vinnitsa 21029, Ukraine; Not yet recruiting

Zaporozhye 69000, Ukraine; Not yet recruiting

London SW17 0QT, United Kingdom; Terminated

London E1 1BB, United Kingdom; Terminated

Southampton S016 6YD, United Kingdom; Terminated

Calgary, Alberta T3B 6A8, Canada; Recruiting

Stuttgart, Baden-Württemberg 70176, Germany; Recruiting

Sabadell, Barcelona 08208, Spain; Terminated

Regensburg, Bayern 93049, Germany; Recruiting

Starnberg, Bayern 82319, Germany; Terminated

Mar del Plata, Buenos Aires B7602CBM, Argentina; Terminated

Tres de Febrero, Buenos Aires 1657, Argentina; Terminated

Los Angeles, California 90095, United States; Terminated

Orange, California 92868-3974, United States; Not yet recruiting

San Diego, California 92123, United States; Recruiting

Buenos Aires, Ciudad Auton. de Buenos Aires C1431FWO, Argentina; Terminated

Buenos Aires, Ciudad Auton. de Buenos Aires C1181ACH, Argentina; Terminated

Denver, Colorado 80204, United States; Not yet recruiting

Paraná, Entre Ríos E3100FN, Argentina; Terminated

Ecatepec de Morelos, Estado de Mexico 55020, Mexico; Recruiting

Toluca de Lerdo, Estado de Mexico 50170, Mexico; Terminated

Pensacola, Florida 32504, United States; Not yet recruiting

Honolulu, Hawaii 96826-1032, United States; Terminated

South Bend, Indiana 46601, United States; Not yet recruiting

Guadalajara, Jalisco C.P. 44280, Mexico; Recruiting

Bangalore, Karn?taka 560054, India; Terminated

Louisville, Kentucky 40202, United States; Not yet recruiting

San Juan de Miraflores, Lima LIMA 29, Peru; Terminated

New Orleans, Louisiana 70118, United States; Not yet recruiting

Springfield, Massachusetts 01199, United States; Recruiting

Belo Horizonte, Minas Gerais 30150-221, Brazil; Terminated

Wuppertal, Nordrhein-Westfalen 42283, Germany; Recruiting

Monterrey, Nuevo Leon 64000, Mexico; Terminated

Akron, Ohio 44308-1062, United States; Terminated

Cleveland, Ohio 44106, United States; Not yet recruiting

Toledo, Ohio 43606, United States; Not yet recruiting

Hamilton, Ontario L8N 3Z5, Canada; Recruiting

Montreal, Quebec H3H 1P3, Canada; Recruiting

Dresden, Sachsen 01307, Germany; Not yet recruiting

Leipzig, Sachsen 04103, Germany; Not yet recruiting

Houston, Texas 77030, United States; Not yet recruiting

Temple, Texas 76508, United States; Not yet recruiting

Lucknow, Uttar Pradesh 226003, India; Terminated

Sheffield, York S10 2TH, United Kingdom; Terminated

Merida, Yucatán 97000, Mexico; Terminated

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Starting date: July 2010
Last updated: February 6, 2013