Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection

Condition(s) targeted: Intraabdominal Infections

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

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

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

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:

Number of Subjects With Adverse Events

Number of Subjects With Clinical Cardiac Adverse Events

Number of Subjects With Musculoskeletal Adverse Events

Secondary outcome:

Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term

Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3

QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

Corrected QT (QTc) Interval Calculated (Calc) Bazett Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

Corrected QT (QTc) Interval Calculated (Calc) Fridericia Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3

Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3

Clinical Response at Test-of-Cure (TOC) Visit

Bacteriological Response at Test-of-Cure (TOC) Visit

Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI)

Clinical Response at a 'During Therapy' Visit

Bacteriological Response at a 'During Therapy' Visit

Clinical Response at the End-of-Treatment (EOT) Visit

Bacteriological response at the End of Treatment (EOT) 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

Córdoba 5000, Argentina

Genk 3600, Belgium

Gent 9000, Belgium

Leuven 3000, Belgium

Pleven 5800, Bulgaria

Plovdiv 4002, Bulgaria

Ruse 7002, Bulgaria

Sofia 1606, Bulgaria

Stara Zagora 6000, Bulgaria

Santiago 8360160, Chile

Santiago, Chile

Temuco 4781173, Chile

Olomouc 77520, Czech Republic

Prague 150 06, Czech Republic

Athens 115 27, Greece

Budapest 1086, Hungary

Gyor 9024, Hungary

Miskolc 3501, Hungary

Bangalore 560001, India

Daugavpils LV-5417, Latvia

Rezekne LV-4601, Latvia

Riga LV1004, Latvia

Kaunas LT-50009, Lithuania

Vilnius LT-08661, Lithuania

México, D.F. 04530, Mexico

Cusco, Peru

Lima 31, Peru

Lima LIMA 1, Peru

Lima, Peru

Bucharest 41451, Romania

Cluj Napoca 400370, Romania

Constanta 900591, Romania

Iasi 700309, Romania

Targu Mures 540136, Romania

Timisoara 300011, Romania

Chelyabinsk 454076, Russian Federation

Izhevsk 426034, Russian Federation

Kaluga 248007, Russian Federation

Kazan 420012, Russian Federation

Moscow 105077, Russian Federation

Moscow 115280, Russian Federation

Moscow 119415, Russian Federation

Rostov-on-Don 344091, Russian Federation

Smolensk 214019, Russian Federation

Vladikaykaz 362007, Russian Federation

Belgrade 11000, Serbia

Nis 18000, Serbia

Madrid 28009, Spain

Madrid 28041, Spain

Madrid 28046, Spain

Dnipropetrovsk 49100, Ukraine

Donetsk 83052, Ukraine

Ivano-Frankovsk 76006, Ukraine

Lviv 79004, Ukraine

Simferopol 95034, Ukraine

Vinnitsa 21029, Ukraine

Zaporozhye 69000, Ukraine

London E1 1BB, United Kingdom

London SW17 0QT, United Kingdom

Sheffield S10 2TH, United Kingdom

Southampton S016 6YD, United Kingdom

Calgary, Alberta T3B 6A8, Canada

Stuttgart, Baden-Württemberg 70176, Germany

Sabadell, Barcelona 08208, Spain

Regensburg, Bayern 93049, Germany

Starnberg, Bayern 82319, Germany

Mar del Plata, Buenos Aires B7602CBM, Argentina

Tres de Febrero, Buenos Aires 1657, Argentina

Los Angeles, California 90095, United States

Orange, California 92868-3974, United States

San Diego, California 92123, United States

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

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

Denver, Colorado 80204, United States

Paraná, Entre Ríos E3100FN, Argentina

Ecatepec de Morelos, Estado de Mexico 55020, Mexico

Toluca de Lerdo, Estado de Mexico 50170, Mexico

Pensacola, Florida 32504, United States

Honolulu, Hawaii 96826-1032, United States

South Bend, Indiana 46601, United States

Guadalajara, Jalisco C.P. 44280, Mexico

Bangalore, Karn?taka 560054, India

Louisville, Kentucky 40202, United States

San Juan de Miraflores, Lima LIMA 29, Peru

New Orleans, Louisiana 70118, United States

Springfield, Massachusetts 01199, United States

Belo Horizonte, Minas Gerais 30150-221, Brazil

Wuppertal, Nordrhein-Westfalen 42283, Germany

Monterrey, Nuevo Leon 64000, Mexico

Akron, Ohio 44308-1062, United States

Cleveland, Ohio 44106, United States

Toledo, Ohio 43606, United States

Hamilton, Ontario L8N 3Z5, Canada

Montreal, Quebec H3H 1P3, Canada

Dresden, Sachsen 01307, Germany

Leipzig, Sachsen 04103, Germany

Houston, Texas 77030, United States

Temple, Texas 76508, United States

Lucknow, Uttar Pradesh 226003, India

Merida, Yucatán 97000, Mexico

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Starting date: July 2010
Last updated: July 1, 2015