Moxifloxacin in Pediatric Subjects With Complicated Intra... | NCT01069900

NCT01069900

ID	Type	Description	Link
1962 (Avelox pediatrics)	Other Identifier	Company internal
2009-015578-37	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Moxifloxacin (Avelox, BAY12-8039)	Experimental	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days.	Drug: Moxifloxacin (Avelox, BAY12-8039) Drug: Ertapenem placebo Drug: Amoxicillin/Clavulanate placebo
Comparator Ertapenem	Active Comparator	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.	Drug: Ertapenem Drug: Amoxicillin/Clavulanate Drug: Moxifloxacin placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Moxifloxacin (Avelox, BAY12-8039)	Drug	For subjects 12 to less than (<) 18 years of age and weighing at least 45 kilograms (kg), the dose of moxifloxacin will be 400 milligrams (mg), once daily (OD). Subjects 12 to < 18 years of age and weighing less than 45 kg, the dose of moxifloxacin will be 4 mg/kg twice daily (BID), every 12 hours (q12h), not exceeding 400 mg/day. Subjects 6 to < 12 years of age the dose of moxifloxacin will be 4mg/kg, q12h, not exceeding 400 mg/day. Subjects 2 to less than 6 years of age the dose of moxifloxacin will be 5mg/kg, q12h, not exceeding 400 mg/day. Subjects 3 months to less than 2 years of age the dose of moxifloxacin will be 6mg/kg q12h IV, not exceeding 400 mg/day. Subjects who were switched from IV to PO therapy, 400 mg or 50 mg moxifloxacin tablets were provided.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Adverse Events	An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Number of Subjects With Clinical Cardiac Adverse Events		Clinical cardiac event related to QT interval were recorded from treatment start until day 3 of treatment. All other clinical cardiac events were recorded from treatment start to test of cure visit, up to day 56.
Number of Subjects With Musculoskeletal Adverse Events		All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.

Secondary Outcomes

Measure	Description	Time Frame
Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term	Musculoskeletal adverse events were classified as following SOCs (preferred terms): "injury, poisoning and procedural complications" (forearm fracture, joint injury, ligament sprain, muscle strain) "musculoskeletal and connective tissue disorders" (arthralgia, joint swelling, musculoskeletal pain, myalgia). Incidence rates were reported as percentage of subjects categorized under preferred terms.

Eligibility Module

Eligibility 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

Contacts/Locations Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		San Diego	California	92123	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29356761	Result	Wirth S, Emil SGS, Engelis A, Digtyar V, Criollo M, DiCasoli C, Stass H, Willmann S, Nkulikiyinka R, Grossmann U; MOXIPEDIA Study Group. Moxifloxacin in Pediatric Patients With Complicated Intra-abdominal Infections: Results of the MOXIPEDIA Randomized Controlled Study. Pediatr Infect Dis J. 2018 Aug;37(8):e207-e213. doi: 10.1097/INF.0000000000001910.

Label	URL
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
BG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00012.05± 3.66 BG00112.046± 3.495 BG00212.049± 3.602

Age, Customized

Number

Subjects

Title

Denominators

Categories

12 - < 18 years

Title	Measurements
	BG000190 BG00194 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000124 BG00153 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With Adverse Events

An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

Posted

Number

Subjects

All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Units	Counts
Participants	OG000301 OG001150

Title

Denominators

Categories

Any AE

Title	Measurements
	OG000175 OG00182

Any SAE

Title	Measurements
	OG000

Primary

Number of Subjects With Clinical Cardiac Adverse Events

Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

Posted

Number

Subjects

Clinical cardiac event related to QT interval were recorded from treatment start until day 3 of treatment. All other clinical cardiac events were recorded from treatment start to test of cure visit, up to day 56.

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Units	Counts
Participants

Primary

Number of Subjects With Musculoskeletal Adverse Events

Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

Posted

Number

Subjects

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Units	Counts
Participants

Secondary

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

Musculoskeletal adverse events were classified as following SOCs (preferred terms): "injury, poisoning and procedural complications" (forearm fracture, joint injury, ligament sprain, muscle strain) "musculoskeletal and connective tissue disorders" (arthralgia, joint swelling, musculoskeletal pain, myalgia). Incidence rates were reported as percentage of subjects categorized under preferred terms.

Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

Posted

Number

95% Confidence Interval

Percentage of subjects

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Secondary

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

"N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.

Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

Posted

Mean

Standard Deviation

Beats per minute (bpm)

Baseline (Pre-dose), Day 1, Day 3

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Units	Counts

Secondary

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

The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.

Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

Posted

Mean

Standard Deviation

milliseconds

Baseline (Pre-dose), Day 1, Day 3

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Secondary

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

The RR interval refers to the respective time interval in the Electrocardiogram. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.

Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

Posted

Mean

Standard Deviation

milliseconds

Baseline (Pre-dose), Day 1, Day 3

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Units

Secondary

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

The QRS interval represents the time it takes for ventricular depolarization to occur. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.

Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

Posted

Mean

Standard Deviation

milliseconds

Baseline (Pre-dose), Day 1, Day 3

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Units

Secondary

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

The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.

Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

Posted

Mean

Standard Deviation

milliseconds

Baseline (Pre-dose), Day 1, Day 3

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Secondary

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

QTc interval Calc Bazett represent the interval corrected for heart rate (QTc) milliseconds (msec) which was calculated by Bazett's method. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.

Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

Posted

Mean

Standard Deviation

milliseconds

Baseline (Pre-dose), Day 1, Day 3

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Secondary

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

QTc interval Calc Fridericia represent the interval corrected for heart rate (QTc) msec which was calculated by Fridericia's method. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.

Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

Posted

Mean

Standard Deviation

milliseconds

Baseline (Pre-dose), Day 1, Day 3

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Secondary

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

A significant QTc prolongation was considered when the QTc value was more than (>) upper limit of normal (ULN) range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported.

Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

Posted

Number

Percentage of subjects

Baseline (Pre-dose), Day 1, Day 3

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Secondary

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

A significant QTc prolongation was considered when the QTc value was more than ULN range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported.

Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

Posted

Number

Percentage of subjects

Baseline (Pre-dose), Day 1, Day 3

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Secondary

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

Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported.

Safety analysis set with subjects evaluable for this outcome

Posted

Number

Percentage of subjects

28 to 42 days

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Secondary

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

Bacteriological responses were graded as presumed persistence, presumed eradication or indeterminate.

'Presumed persistence' was applicable for subjects judged to be clinical failures, and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded and invasive procedures are not warranted; índeterminate' was applicable when the bacteriological response to the study drug was not valid for any reason (eg, pre-treatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at TOC were reported.

Safety analysis set with subjects evaluable for this outcome

Posted

Number

Percentage of subjects

28 to 42 days

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Secondary

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

Safety analysis set with subjects evaluable for this outcome

Posted

Number

Percentage of subjects

28 to 42 days

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Secondary

Clinical Response at a 'During Therapy' Visit

Clinical responses during therapy visit were graded as clinical improvement, clinical failure, or indeterminate. Clinical improvement defined as a reduction in the severity and/or the number of signs and symptoms of infection; 'clinical failure' defined as a failure to respond or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy.

'Indeterminate' defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent, receipt of an effective concomitant antibacterial for an indication other than the study indication and receipt of less than 3 full days of study drug, etc). Percentage of subjects with clinical response during therapy visit were reported.

Safety analysis set with subjects evaluable for this outcome

Posted

Number

Percentage of subjects

Day 3 to Day 5

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Secondary

Bacteriological Response at a 'During Therapy' Visit

Bacteriological response during therapy were graded as presumed persistence, presumed eradication, or indeterminate'Presumed persistence' is applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation;'presumed eradication' is defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate is applicable when the bacteriological response to the study drug is not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject is not judged a clinical failure). Percentage of subjects with bacteriological response during therapy visit were reported

Safety analysis set with subjects evaluable for this outcome

Posted

Number

Percentage of subjects

Day 3 to Day 5

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Secondary

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

Clinical responses at EOT were graded as resolution, failure, or indeterminate. 'Resolution' defined as a disappearance of signs and symptoms related to the infection or sufficient improvement of clinical signs and symptoms related to the infection and the subject does not require any further antibiotic therapy or surgical intervention; 'failure' defined as worsening or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy; 'indeterminate' is defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent; receipt of less than 3 full days of study drug; receipt of an effective concomitant antibacterial for an indication other than study indication; etc). Percentage of subjects with clinical response at EOT were reported.

Safety analysis set with subjects evaluable for this outcome

Posted

Number

Percentage of subjects

Day 5 to Day 14

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem

Secondary

Bacteriological Response at the End of Treatment (EOT) Visit

Bacteriological response at EOT were grades as presumed persistence, presumed eradication or indeterminate. 'presumed persistence' was applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate' is applicable when the bacteriological response to the study drug was not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at EOT were reported.

Safety analysis set with subjects evaluable for this outcome

Posted

Number

Percentage of subjects

Day 5 to Day 14

ID	Title	Description
OG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
OG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Moxifloxacin (Avelox, BAY12-8039)	Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days.			20	301	127	301
EG001	Comparator Ertapenem	Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.			6	150	63	150

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected150 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected150 at risk
Constipation	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected150 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected150 at risk
Ileal perforation	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected150 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 events2 affected301 at risk EG0010 events0 affected150 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 events3 affected301 at risk EG0012 events2 affected150 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected150 at risk
Faecalith	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected150 at risk
Functional gastrointestinal disorder	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 events2 affected301 at risk EG0010 events0 affected150 at risk
Surgical failure	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected150 at risk
Abdominal wall abscess	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected150 at risk
Cellulitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected150 at risk
Peritoneal abscess	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected150 at risk
Wound infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected150 at risk
Abdominal infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected150 at risk
Abdominal abscess	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0003 events3 affected301 at risk EG0010 events0 affected150 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected150 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected150 at risk
Abdominal wound dehiscence	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected150 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected150 at risk
Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected150 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected150 at risk
Idiopathic generalised epilepsy	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected150 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0008 events8 affected301 at risk EG0013 events3 affected150 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00012 events11 affected301 at risk EG0011 events1 affected150 at risk
Nausea	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0012 events2 affected150 at risk
Vomiting	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00022 events20 affected301 at risk EG00112 events12 affected150 at risk
Pyrexia	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0006 events6 affected301 at risk EG0014 events4 affected150 at risk
Infusion site phlebitis	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0006 events4 affected301 at risk EG0010 events0 affected150 at risk
Wound infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG00013 events13 affected301 at risk EG0016 events6 affected150 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0004 events4 affected301 at risk EG0012 events2 affected150 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG00026 events26 affected301 at risk EG00114 events14 affected150 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0004 events3 affected301 at risk EG0012 events2 affected150 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG00016 events16 affected301 at risk EG00110 events10 affected150 at risk
Incision site inflammation	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0002 events2 affected301 at risk EG0013 events3 affected150 at risk
Procedural vomiting	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0014 events4 affected150 at risk
Alanine aminotransferase increased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG0003 events3 affected301 at risk EG0012 events2 affected150 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG0002 events2 affected301 at risk EG0013 events3 affected150 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG0004 events4 affected301 at risk EG0012 events2 affected150 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG00031 events28 affected301 at risk EG0014 events4 affected150 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG0002 events2 affected301 at risk EG0012 events2 affected150 at risk
Lipase increased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0012 events2 affected150 at risk
Hyperlipasaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected301 at risk EG0013 events2 affected150 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG00036 events9 affected301 at risk EG0012 events2 affected150 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0012 events2 affected150 at risk
Headache	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0006 events6 affected301 at risk EG0012 events2 affected150 at risk
Abdominal cavity drainage	Surgical and medical procedures	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected301 at risk EG0012 events2 affected150 at risk
Phlebitis	Vascular disorders	MedDRA (17.1)	Non-systematic Assessment	EG0008 events8 affected301 at risk EG0010 events0 affected150 at risk

ID	Term
D059413	Intraabdominal Infections

ID	Term
D000077266	Moxifloxacin
D000077727	Ertapenem
D019980	Amoxicillin-Potassium Clavulanate Combination
D000658	Amoxicillin

Ancestor Terms

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D015780	Carbapenems
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930	Organic Chemicals
D019818	Clavulanic Acid
D002969	Clavulanic Acids
D000667	Ampicillin
D010400	Penicillin G
D010406	Penicillins
D013457	Sulfur Compounds
D004338	Drug Combinations
D004364	Pharmaceutical Preparations

Units	Counts
Participants	OG000301 OG001150

Units	Counts
Participants	OG000301 OG001150

Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.