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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00230971




Registration number
NCT00230971
Ethics application status
Date submitted
30/09/2005
Date registered
3/10/2005
Date last updated
25/02/2013

Titles & IDs
Public title
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
Scientific title
A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-abdominal Infection
Secondary ID [1] 0 0
3074A1-315
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appendicitis 0 0
Cholecystitis 0 0
Diverticulitis 0 0
Intra-Abdominal Abscess 0 0
Intra-Abdominal Infection 0 0
Peritonitis 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Surgery 0 0 0 0
Other surgery
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tigecycline
Treatment: Drugs - ceftriaxone plus metronidazole

Active Comparator: A -

Active Comparator: B -


Treatment: Drugs: tigecycline
every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)

Treatment: Drugs: ceftriaxone plus metronidazole
Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit - CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made. Clinical response was assigned by investigator per protocol-specified guidelines and defined as: test article and initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. TOC performed 10-28 days after last dose of study drug.
Timepoint [1] 0 0
up to 6 weeks
Secondary outcome [1] 0 0
Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit - ME population were subjects who were clinically evaluable and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.
Timepoint [1] 0 0
up to 6 weeks
Secondary outcome [2] 0 0
Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit - Microbiological response was assessed at patient level was the combined responses for all baseline isolates identified in intra-abdominal and blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=No sample for culture, clinical response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=No sample available for culture, clinical response was failure; Superinfection=culture from primary infection site with new isolate not identified at baseline, clinical response was failure.
Timepoint [2] 0 0
up to 6 weeks
Secondary outcome [3] 0 0
Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure - Healthcare resource utilization assessment included days of overall inpatient hospitalization, days of primary inpatient hospitalization, days of Intensive Care Unit (ICU) treatment and days of non-ICU inpatient hospitalization
Timepoint [3] 0 0
up to 6 weeks

Eligibility
Key inclusion criteria
- Clinical diagnosis of complicated intra-abdominal infection that requires surgery
within 24 hours.

- Fever plus other symptoms such as nausea, vomiting, abdominal pain.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cancer

- Medicines that suppress the immune system

- Dialysis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
- Nambour
Recruitment hospital [2] 0 0
- Cairns
Recruitment hospital [3] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
4560 - Nambour
Recruitment postcode(s) [2] 0 0
QLD 4870 - Cairns
Recruitment postcode(s) [3] 0 0
VIC 3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Shanghai
Country [2] 0 0
Denmark
State/province [2] 0 0
Odense
Country [3] 0 0
Finland
State/province [3] 0 0
Lahti
Country [4] 0 0
Finland
State/province [4] 0 0
Seinajoki
Country [5] 0 0
Finland
State/province [5] 0 0
Tampere
Country [6] 0 0
France
State/province [6] 0 0
Marseille
Country [7] 0 0
France
State/province [7] 0 0
Nimes
Country [8] 0 0
France
State/province [8] 0 0
Pierre Benite
Country [9] 0 0
France
State/province [9] 0 0
Saint Denis
Country [10] 0 0
Germany
State/province [10] 0 0
Bochum
Country [11] 0 0
Germany
State/province [11] 0 0
Frankfurt
Country [12] 0 0
Germany
State/province [12] 0 0
Freiburg
Country [13] 0 0
Germany
State/province [13] 0 0
Heidelberg
Country [14] 0 0
Germany
State/province [14] 0 0
Leipzig
Country [15] 0 0
Germany
State/province [15] 0 0
Luebeck
Country [16] 0 0
Germany
State/province [16] 0 0
Muenster
Country [17] 0 0
Germany
State/province [17] 0 0
Tuebingen
Country [18] 0 0
Greece
State/province [18] 0 0
Athens
Country [19] 0 0
Greece
State/province [19] 0 0
Thessaloniki
Country [20] 0 0
Hong Kong
State/province [20] 0 0
New Territories
Country [21] 0 0
Hong Kong
State/province [21] 0 0
Pokfulam
Country [22] 0 0
India
State/province [22] 0 0
Andhra
Country [23] 0 0
India
State/province [23] 0 0
Bhopal
Country [24] 0 0
India
State/province [24] 0 0
Lucknow
Country [25] 0 0
India
State/province [25] 0 0
Mumbai
Country [26] 0 0
India
State/province [26] 0 0
New Delhi
Country [27] 0 0
Italy
State/province [27] 0 0
Brescia
Country [28] 0 0
Italy
State/province [28] 0 0
Genova
Country [29] 0 0
Italy
State/province [29] 0 0
Pavia
Country [30] 0 0
Italy
State/province [30] 0 0
Rome
Country [31] 0 0
Italy
State/province [31] 0 0
Udine
Country [32] 0 0
Italy
State/province [32] 0 0
Vicenza
Country [33] 0 0
Philippines
State/province [33] 0 0
Manila
Country [34] 0 0
Philippines
State/province [34] 0 0
Quezon City
Country [35] 0 0
Portugal
State/province [35] 0 0
Almada
Country [36] 0 0
Portugal
State/province [36] 0 0
Coimbra
Country [37] 0 0
Portugal
State/province [37] 0 0
Porto
Country [38] 0 0
Saudi Arabia
State/province [38] 0 0
Riyadh
Country [39] 0 0
South Africa
State/province [39] 0 0
Bellville
Country [40] 0 0
South Africa
State/province [40] 0 0
Kuilsriver
Country [41] 0 0
South Africa
State/province [41] 0 0
Parow
Country [42] 0 0
South Africa
State/province [42] 0 0
Pietermaritzburg
Country [43] 0 0
South Africa
State/province [43] 0 0
Pretoria
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
Spain
State/province [45] 0 0
Bilbao
Country [46] 0 0
Spain
State/province [46] 0 0
Madrid
Country [47] 0 0
Spain
State/province [47] 0 0
Murcia
Country [48] 0 0
Switzerland
State/province [48] 0 0
Bern
Country [49] 0 0
Switzerland
State/province [49] 0 0
Geneva
Country [50] 0 0
Switzerland
State/province [50] 0 0
Lugano
Country [51] 0 0
Switzerland
State/province [51] 0 0
Zurich
Country [52] 0 0
Taiwan
State/province [52] 0 0
Changhua
Country [53] 0 0
Taiwan
State/province [53] 0 0
Taichung
Country [54] 0 0
Taiwan
State/province [54] 0 0
Tainan
Country [55] 0 0
Taiwan
State/province [55] 0 0
Taipei
Country [56] 0 0
Taiwan
State/province [56] 0 0
Tao-yuan
Country [57] 0 0
Turkey
State/province [57] 0 0
Ankara
Country [58] 0 0
Turkey
State/province [58] 0 0
Istanbul
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Cheshire
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Birmingham
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Wigan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus
metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy
through the test-of-cure assessment. Safety evaluations will occur through the treatment and
post-treatment periods and continue through resolution or stability of the adverse event(s).
Trial website
https://clinicaltrials.gov/show/NCT00230971
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Wyeth is now a wholly owned subsidiary of Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications