Intra-abdominal InfectionPhase 4NCT01721408

A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection

A Phase 4 study testing Tigecycline and Imipenem/cilastatin in people with Intra-abdominal Infection, run by Pfizer at 47 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Intra-abdominal Infection
What is being tested?: Tigecycline and Imipenem/cilastatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 470 participants
Where: 47 sitesChina
Study dates: Nov 2012to Oct 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Hospitalized male or female subjects, at least 18 year of age.
Complicated intra-abdominal infection is present at most under two weeks duration.
Minimal clinical criteria at the time of intra-abdominal infection diagnosis or highly suspected intra-abdominal infection.

Who cannot join

Anticipated length of antibiotic therapy less than 5 days or the likelihood that the subject will not complete the course of treatment.
Intra-abdominal infection known to be caused by 1 or more bacterial pathogens not susceptible to both of the study drugs.
Had accepted non-study antibiotics more than 24 hr within 72 hrs before enrollment except for subjects declared prior failures.

Trial locations and contacts

47 sites in 1 country.

City, postcode or hospital

47 sites in 1 country

China47 sites

Anqing City Hospital
Anqing, Anhui, 246003
Baotou Central Hospital
Baotou, Inner Mongolia, 014000
China Meitan General Hospital/General Surgery Department
Beijing, 100028
Department of General Surgery,Beijing Shijitan Hospital,Capital Medical University
Beijing, 100038
Navy General Hospital PLA China/Genaral Surgery Department
Beijing, 100048
Peking University Third Hospital
Beijing, 100191
Department of General Surgery, Peking Union Medical College Hospital
Beijing, 100730
Binzhou Medical University Hospital
Binzhou, Shandong, 256603
Jilin Province People's Hospital
Changchun, Jilin, 130021
The First Hospital of Jilin University/Surgery
Changchun, Jilin, 130021
The Second Hospital of Jilin University
Changchun, Jilin, 130041
Xiangya Hospital Central-South University/General Surgery
Changsha, Hunan, 410008
The Third Xiangya Hospital of Central South University/Department of General Surgery
Changsha, Hunan, 410013
The Third Hospital of Changsha/Department of Surgery
Changsha, Hunan, 410015
Department of General Surgery, Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
General Hospital of Chengdu Military Region of PLA
Chengdu, Sichuan, 610083
Department of General Surgery, the First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, 510120
The First Affiliated Hospital of JiNan University/General Surgery
Guangzhou, Guangdong, 510630
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001
HaiKou Municipal People's Hospital
Haikou, Hainan, 570208
Hainan Provincial People's Hospital
Haikou, Hainan, 570311
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
The Affiliated Jiangyin Hospital of Southeast University Medical College, General Surgery Department
Jiangyin, Jiangsu, 214400
First people's Hospital of Kunming
Kunming, Yunnan, 650011
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, 317000
Lishui People's Hospital/Intensive Care Unit
Lishui, Zhejiang, 323000
The Third People's Hospital of Hainan Province/department of general surgery
Sanya, Hainan, 572000
Shanghai Fengxian District Central Hospital, Department of Surgery
Shanghai, Shanghai Municipality, 201400
Institute of Antibiotics, Hua Shan Hospital, Fudan University
Shanghai, 200040
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
Zhongshan Hospital Affiliated to Fudan University Qingpu Branch, Department of Surgery,
Shanghai, 201700
The First Hospital of Shantou University School of Medicine
Shantou, Guangdong, 515041
Shenzhen Second People's Hosptial/Department of hepatobiliary surgery
Shenzhen, Guangdong, 518039
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Tianjin Union Medical Center
Tianjin, 300000
Department of General Surgery, Tianjin Medical University General Hospital
Tianjin, 300052
Tianjin Nankai Hospital
Tianjin, 300100
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Tongji Medical College, Huazhong University of Science and Technology, The Central Hospital of Wuhan
Wuhan, Hubei, 430014
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Zhongnan Hospital of Wuhan University/Intensive Care Unit
Wuhan, Hubei, 430071
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004
Department of Hepatobiliary Surgery, Peking University People's Hospital
Xicheng District, Beijing Municipality, 100044
Qinghai Provincial People's Hospital
Xining, Qinghai, 810007
Yangzhou No.1 People's Hospital
Yangzhou, Jiangsu, 225001
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 363000

Other trials in China

About this study

Official title: A Multicenter, Double-blind, Randomized, Comparison Study Of The Efficacy And Safety Of Tigecycline To Imipenem/Cilastatin To Treat Complicated Intra-abdominal Infections In Hospitalized Subjects.

This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection.

Conditions: Intra-abdominal Infection
Being tested: Tigecycline, Imipenem/cilastatin
Medical subject headings: Intraabdominal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TigecyclineDrug
every 12 hours (an initial intravenous dose of 100 mg followed by 50 mg twice a day approximately every 12 hours) and placebo intravenous doses every 12 hours beginning 6 hours after the initial intravenous dose of tigecycline for at least for 5 days and up to 14 days.
Imipenem/cilastatinDrug
every 6 hours intravenously, and the imipenem/cilastatin will be dosed by 500mg/500mg for the subjects with creatinine clearance equal or above 71ml/min/1.73m2 or dose will be adjusted by Schedule of Study Drug Administration for Subjects with Renal Impairment.

Study groups in NCT01721408
Study group	Role	What they receive
Group A	Experimental	Not described Receives: Drug: Tigecycline
Group B	Active comparator	Not described Receives: Drug: Imipenem/cilastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population
The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).
Measured: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population
The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).
Measured: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)

Secondary outcomes (2)

Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) Population
The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).
Measured: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
Microbiological Response at the Subject Level in the ME Population at the TOC Assessment
The microbiological response at the subject level was described according to the following definitions of efficacy. Eradication (documented or presumed): none of the baseline pathogens were present in repeat intra-abdominal cultures from the original site of infection taken during the study or a clinical response of cure precluded the necessity of a repeat intra-abdominal culture. Persistence (documented or presumed): documented: any baseline intra-abdominal pathogen was present in the cultures obtained from the original site of the intra-abdominal abscess, peritonitis, or surgical wound infection during the study; Presumed: repeat microbiological data were not obtained for a participant with a clinical response of failure. Superinfection: Emergence of a new pathogen during therapy, at the site of infection with emergence or worsening of clinical signs and symptoms of infection.
Measured: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Oct 2015

First posted5 Nov 2012 (estimated)
Study startNov 2012
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Intra-abdominal InfectionStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 470 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01721408
Sponsor's protocol ID: B1811185
Status last verified: Sep 2017
First submitted: 31 Oct 2012
Last updated: 9 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Chen Y, Zhu D, Zhang Y, Zhao Y, Chen G, Li P, Xu L, Yan P, Hickman MA, Xu X, Tawadrous M, Wible M. A multicenter, double-blind, randomized, comparison study of the efficacy and safety of tigecycline to imipenem/cilastatin to treat complicated intra-abdominal infections in hospitalized subjects in China. Ther Clin Risk Manag. 2018 Nov 30;14:2327-2339. doi: 10.2147/TCRM.S171821. eCollection 2018.
PubMed 30584308

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-blind, Randomized, Comparison Study Of The Efficacy And Safety Of Tigecycline To Imipenem/Cilastatin To Treat Complicated Intra-abdominal Infections In Hospitalized Subjects.
ClinicalTrials.gov ID: NCT01721408
Acronym / sponsor ID: B1811185
Conditions: Intra-abdominal Infection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 470 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2012 (actual)
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 5 Nov 2012 (estimated)
Results: Posted 9 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Drug: Tigecycline
Group B	Active comparator	Drug: Imipenem/cilastatin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Hospitalized male or female subjects, at least 18 year of age.
Complicated intra-abdominal infection is present at most under two weeks duration.
Minimal clinical criteria at the time of intra-abdominal infection diagnosis or highly suspected intra-abdominal infection.

Key exclusion criteria (3 listed)

Anticipated length of antibiotic therapy less than 5 days or the likelihood that the subject will not complete the course of treatment.
Intra-abdominal infection known to be caused by 1 or more bacterial pathogens not susceptible to both of the study drugs.
Had accepted non-study antibiotics more than 24 hr within 72 hrs before enrollment except for subjects declared prior failures.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tigecyclineevery 12 hours (an initial intravenous dose of 100 mg followed by 50 mg twice a day approximately every 12 hours) and placebo intravenous doses every 12 hours beginning 6 hours after the initial intravenous dose of tigecycline for at least for 5 days and up to 14 days.	Drug	Group A
Imipenem/cilastatinevery 6 hours intravenously, and the imipenem/cilastatin will be dosed by 500mg/500mg for the subjects with creatinine clearance equal or above 71ml/min/1.73m2 or dose will be adjusted by Schedule of Study Drug Administration for Subjects with Renal Impairment.	Drug	Group B

Primary outcome

Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population
Time frame: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).
Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population
Time frame: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).

2 secondary outcomes

Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) Population
Time frame: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
Microbiological Response at the Subject Level in the ME Population at the TOC Assessment
Time frame: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)

Results and safety

Results posted to the registry on 9 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tigecycline 50mg	232	196
Imipenem/Cilastatin	231	207

Primary outcome: Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population

Time frame: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Tigecycline 50mg n = 207	Imipenem/Cilastatin n = 205
Cure	89.9 (84.9 to 93.6)	96.6 (93.1 to 98.6)
Failure	10.1 (6.4 to 15.1)	3.4 (1.4 to 6.9)

Tigecycline 50mg vs Imipenem/Cilastatin: Difference in percentage: -6.7 (95% CI -12.0 to -1.4), p = 0.0008, See method of CI

Population analysed: The CE population was defined as all clinical modified intent-to-treat (c-mITT) participants who satisfied clinical evaluability criteria and had no major protocol violations.

Primary outcome: Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population

Measure	Tigecycline 50mg n = 232	Imipenem/Cilastatin n = 231
Cure	82.8 (77.3 to 87.4)	88.7 (83.9 to 92.5)
Failure	10.3 (6.7 to 15.0)	3.5 (1.5 to 6.7)
Indeterminate	6.9 (4.0 to 11.0)	7.8 (4.7 to 12.0)

Tigecycline 50mg vs Imipenem/Cilastatin: Difference in percentage: -6.0 (95% CI -12.8 to 0.8), p = 0.0040, See method of CI

Population analysed: The MITT population was defined as all randomized participants who received at least 1 dose of investigational product.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose of study treatment (for non-serious AEs)/the time that the subject provided informed consent (for SAEs) through post therapy follow-up (28 days after the last dose of therapy). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tigecycline 50mg	32 of 232 (13.8%)	57 of 232 (24.6%)	Not reported
Imipenem/Cilastatin	16 of 232 (6.9%)	34 of 232 (14.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30584308Chen Y, Zhu D, Zhang Y, Zhao Y, Chen G, Li P, Xu L, Yan P, Hickman MA, Xu X, Tawadrous M, Wible M. A multicenter, double-blind, randomized, comparison study of the efficacy and safety of tigecycline to imipenem/cilastatin to treat complicated intra-abdominal infections in hospitalized subjects in China. Ther Clin Risk Manag. 2018 Nov 30;14:2327-2339. doi: 10.2147/TCRM.S171821. eCollection 2018.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

47 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tigecycline and Imipenem/cilastatin in people with Intra-abdominal Infection, run by Pfizer at 47 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population (time frame: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01721408, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018.