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 - Moxifloxacin in pediatric subjects with complicated intra-abdominal infection

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2009-015578-37-BE
• Date of registration: 23/02/2010
• Prospective Registration: Yes
• Primary sponsor: Bayer HealthCare AG
• Public 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 - Moxifloxacin in pediatric subjects with complicated intra-abdominal infection
• Scientific 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 - Moxifloxacin in pediatric subjects with complicated intra-abdominal infection
• Date of first enrolment: 21/06/2010
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015578-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Bulgaria, Czech Republic, Germany, Greece, Hungary, Latvia, Lithuania, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
1. Hospitalized males or females 3 months to 17 years of age.
2. Able to obtain parental or legal guardian written informed consent and assent from subjects as applicable by local laws and regulations.
3. 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.
4. If the subject is a female of child-bearing potential she must have a negative pregnancy test at the screening visit, be capable of practicing one of the following methods of contraception, and agree to continue the same method for 1 month following the TOC visit: Oral contraceptive at a stable dose for one menstrual cycle prior to the start of the study, contraceptive implant inserted at least one month prior to the start of the study, or contraceptive injection administered one month prior to the start of the study; intrauterine device; barrier method plus spermicide; spousal/partner sterility; or abstinence. Subjects taking oral contraceptives should additionally use barrier contraception plus spermicide or abstinence during study drug exposure.
5. 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, and/or
• Intra-abdominal abscess, and/or
• 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:
?• Tenderness (with or without rebound), involuntary guarding, absent or diminished bowel sounds, or abdominal wall rigidity
• 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 (body temperature > 38.0°C (100.4 °Fahrenheit) oral; > 38.5°C (101.3° Fahrenheit) rectal or tympanic membrane)
• Leukocytosis (white blood cell [WBC] = 12,000 cells/mm3)
AND
The subject must be scheduled for a surgical procedure (laparotomy or laparoscopy) or percutaneous drainage
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Presumed spontaneous bacterial peritonitis
2. All pancreatic processes including pancreatic sepsis, peripancreatic sepsis, or an cIAI secondary to pancreatitis
3. 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
4. Infections originating from the female genital tract
5. Known severe immunosuppression (eg, known neutropenia with absolute neutrophil count < 1000/mm3 caused by immunosuppressant therapy or malignancy, known lymphopenia with absolute CD4 + T-cell count < 200/mm3, presenting with an Acquired Immunodeficiency Syndrome [AIDS]-defining event and/or concomitant antiretroviral therapy [Note: Human immuno-deficiency virus {HIV} testing is not required for this study protocol], chronic treatment [= 2 weeks] with known immunosuppressive therapy [including treatment with systemic prednisone or equivalent] or any other congenital or acquired immune defect or 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.
6. Congenital or documented acquired QT prolongation
7. Receiving concomitant treatment with QT prolonging drugs
8. History of tendon disease/disorder related to quinolone treatment
9. Pathogenic organisms suspected or identified (eg, Pseudomonas) which are resistant to any of the study drugs
10. 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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Complicated intra-abdominal infections (cIAI)
MedDRA version: 12.0 Level: LLT Classification code 10056570 Term: Intra-abdominal infection

Intervention(s)

Trade Name: Avalox 400 mg / 250 ml Infusionslösung
Product Name: moxifloxacin
Product Code: BAY12-8039
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: MOXIFLOXACIN HYDROCHLORIDE
CAS Number: 186826868
Current Sponsor code: BAY12-8039
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1.6-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: Avalox p.o. (film coated tablet)
Product Name: moxifloxacin
Product Code: BAY12-8039
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MOXIFLOXACIN HYDROCHLORIDE
CAS Number: 186826868
Current Sponsor code: BAY12-8039
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: moxifloxacin oral suspension
Product Code: BAY12-8039
Pharmaceutical Form: Oral suspension
INN or Proposed INN: MOXIFLOXACIN HYDROCHLORIDE
CAS Number: 186826868
Current Sponsor code: BAY12-8039
Concentration unit: g/ml gram(s)/millilitre
Concentration type: equal
Concentration number: 2/100-
Pharmaceutical form of the placebo: Oral suspension
Route of administration of the placebo: Oral use

Trade Name: INVANZ
Product Name: ertapenem
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: ERTAPENEM
CAS Number: 153832-46-3
Concentration unit: g gram(s)
Concentration type: up to
Concentration number: 1-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: Co-amoxiclav 400/57mg/5ml Powder for Oral
Suspension (Sandoz Limited)

Product Name: amoxicillin and clavulanic acid
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: AMOXICILLIN
CAS Number: 26787-78-0
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 875-
INN or Proposed INN: CLAVULANIC

Primary Outcome(s)

Secondary Objective: Secondary objectives:
• To evaluate musculoskeletal adverse events (musculoskeletal pain, arthropathy, tendinopathy, gait abnormality, etc)
• To evaluate electrocardiogram (ECG) profiles obtained on Day 1 and Day 3 pre-treatment and post- treatment (serum peak level)
• To evaluate the clinical and bacteriological response at the Test-of-Cure (TOC) visit
• To evaluate the clinical response at the TOC visit among subjects with a bacteriologically confirmed complicated intra-abdominal infection (cIAI)
• To evaluate the clinical and bacteriological response to treatment at a “during therapy” visit (Day 3-5)
• To evaluate the clinical and bacteriological response to treatment at the End-of-Treatment (EOT) visit

Primary end point(s): The primary variable will be safety with a special focus on cardiac and musculoskeletal events.

Main Objective: Primary objective:
• To evaluate the safety of treatment with moxifloxacin (compared to the safety of IV ertapenem followed by PO amoxicillin/clavulanate)

Secondary ID(s)

BAY 12-8039/11643

2009-015578-37-DE

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 22/07/2015
• Date Completed: 21/01/2015
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-015578-37/results