Abscess, Intra-AbdominalPhase 3MEMONCT00629135
Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses
A Phase 3 study testing Moxifloxacin/Metronidazole or Piperacillin/Tazobactam in people with Abscess, Intra-Abdominal, run by Hannover Medical School at 1 site in Germany.
Trial summary
The study is contemplating the antibiotic therapy of intraabdominal abscesses. These abscesses are a serious problem in surgical practice. Associated pathophysiologic effects as for example peritonitis may become life threatening or may lead to extended periods of morbidity with prolonged hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abscess, Intra-Abdominal
- What is being tested?
- Moxifloxacin/Metronidazole or Piperacillin/Tazobactam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- 15 Nov 2005to 15 Aug 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patients who attained full age (18 years) with intra-abdominal abscesses documented by:
- Laparotomy revealing intra-abdominal abscess or macroscopic gastrointestinal perforation OR
- Suspected intra-abdominal abscess and scheduled for operation with at least three of the following criteria:
- fever,
- leucocytosis,
- symptoms referable to the abdominal cavity (nausea, pain),
- tenderness with or without rebound / abdominal wall rigidity,
- radiological evidence for abscess or gastrointestinal perforation.
Who cannot join
- Patients with the following:
- indwelling peritoneal catheter,
- presumed spontaneous bacterial peritonits,
- peripancreatic sepsis or infection secondary to pancreatitis,
- peptic or traumatic perforation of gastrointestinal tract of < 24 h duration,
- traumatic perforation of the small or large bowel of < 12h duration,
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- transmural necrosis of the intestine due to acute embolic, thrombotic or obstructive occlusions,
- acute cholecystitis,
- appendicitis without perforation or abscess,
- required open abdomen techniques for management,
- gynaecological infection,
- known hypersensivity to any of the study drugs,
- lifethreatening disease with life expectancy of less than 48 hours,
- neutropenia with neutrophil count < 1000 cells/µl,
- receiving chronic treatment with imunosuppressant therapy,
- HIV-seropositives with CD4 count < 200 cells/µl,
- end stage hepatic cirrhosis CHILD PUGH C,
- central or peripheral neuropathy,
- bradycardia,
- symptomatic dysrhythmia in medical history,
- syndromes of QTc prolongation or use of concomittant medicaments reported to increase QT interval,
- disorder of the electrolyte balance,
- previous history of tendinopathy with quinolones,
- previously enrolled in the trial or use of any investigational drug within the previous 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Centre, Prospective, Comparative, Open-label, Randomised Study to Evaluate the Efficacy and Tolerability of the Combination of Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses
The study is contemplating the antibiotic therapy of intraabdominal abscesses. These abscesses are a serious problem in surgical practice. Associated pathophysiologic effects as for example peritonitis may become life threatening or may lead to extended periods of morbidity with prolonged hospitalization.
The objective of the sudy is to evaluate whether the combination of Moxifloxacin and Metronidazole is equivalent to Piperacillin / Tazobactam with regard to clinical outcome and eradication of aerobe and anaerobe pathogens in patients with intra-abdominal abscesses.
Read the detailed description
The study is an interventional prospective, comparative, open-label, randomised single-centre study. Adult patients with intra-abdominal abscesses matching the criteria to be included will be enrolled in the study and randomised into one of the Groups: 1. Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily. 2. Piperacillin / Tazobactam 4,5 g administered intravenously three times daily.
Primary study endpoints: Clinical success / failure rate at the Test-of-Cure visit.
Secondary study endpoints: -Bacteriological response at TOC, -Clinical + Bacteriological response at End-of-Treatment-visit, - Course of disease on the basis of clinical and laboratory parameters, -Time to discharge from hospitals, -Duration of hospitalization post-operatively, - safety and tolerability of the study medication, -cost effectiveness of treatment regimes.
- Conditions
- Abscess, Intra-Abdominal
- Being tested
- Moxifloxacin/Metronidazole or Piperacillin/Tazobactam
- Keywords
- abscess, intraabdominal abscess, Moxifloxacine, Moxifloxacin, Metronidazole, Tazobactam, Piperacilline, Piperacillin, Tazobac
- Medical subject headings
- Abdominal Abscess, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin/Metronidazole or Piperacillin/TazobactamDrug
Antibiotic therapy for patients with intra-abdominal abscesses; Intervention consists of antibiotic treatment of the patients with intraabdominal abscess with either the combination of Moxifloxacin and Metronidazole or Piperacillin/Tazobactam.1. Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily. 2. Piperacillin / Tazobactam 4,5 g administered intravenously three times daily.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | For adult patients with intra-abdominal abscesses matching the criteria to be included will and enrolled in the study arm 1: Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily. Receives: Drug: Moxifloxacin/Metronidazole or Piperacillin/Tazobactam |
| 2 | Active comparator | For adult patients with intra-abdominal abscesses matching the criteria to be included will and enrolled in the study arm 2: Piperacillin / Tazobactam 4,5 g administered intravenously three times daily Receives: Drug: Moxifloxacin/Metronidazole or Piperacillin/Tazobactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success / failure rate at the Test-of-Cure visit
clinical success
Measured: 14 days
Secondary outcomes (5)
Clinical + Bacteriological response at End-of-Treatment-visit
microbiology
Measured: 14 days
Time to discharge from hospital
hospital stay
Measured: up to several months
Course of disease on the basis of clinical and laboratory parameters
response to treatment
Measured: several days
safety and tolerability of the study medication
recording of side effects od study medication such as cardiac arrythmias
Measured: 4 to 10 days
cost effectiveness of treatment regimes
total costs of hospital stay
Measured: up to several months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study start15 Nov 2005
- Primary completion15 Aug 2011
- Study completion15 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abscess, Intra-AbdominalStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Michael Winkler, Prof, Principal investigator, Medical School Hannover, Department for abdominal and transplant surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629135
- Sponsor's protocol ID
- MHH-MW-01
- Acronym
- MEMO
- Status last verified
- Jul 2018
- First submitted
- 25 Feb 2008
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Centre, Prospective, Comparative, Open-label, Randomised Study to Evaluate the Efficacy and Tolerability of the Combination of Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses
- ClinicalTrials.gov ID
- NCT00629135
- Acronym / sponsor ID
- MEMO / MHH-MW-01
- Conditions
- Abscess, Intra-Abdominal
- Keywords
- abscess, intraabdominal abscess, Moxifloxacine, Moxifloxacin, Metronidazole, Tazobactam, Piperacilline, Piperacillin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 15 Nov 2005 (actual)
- Primary completion
- 15 Aug 2011 (actual)
- Study completion
- 15 Aug 2011 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is contemplating the antibiotic therapy of intraabdominal abscesses. These abscesses are a serious problem in surgical practice. Associated pathophysiologic effects as for example peritonitis may become life threatening or may lead to extended periods of morbidity with prolonged hospitalization.
The objective of the sudy is to evaluate whether the combination of Moxifloxacin and Metronidazole is equivalent to Piperacillin / Tazobactam with regard to clinical outcome and eradication of aerobe and anaerobe pathogens in patients with intra-abdominal abscesses.
Detailed description
The study is an interventional prospective, comparative, open-label, randomised single-centre study. Adult patients with intra-abdominal abscesses matching the criteria to be included will be enrolled in the study and randomised into one of the Groups: 1. Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily. 2. Piperacillin / Tazobactam 4,5 g administered intravenously three times daily.
Primary study endpoints: Clinical success / failure rate at the Test-of-Cure visit.
Secondary study endpoints: -Bacteriological response at TOC, -Clinical + Bacteriological response at End-of-Treatment-visit, - Course of disease on the basis of clinical and laboratory parameters, -Time to discharge from hospitals, -Duration of hospitalization post-operatively, - safety and tolerability of the study medication, -cost effectiveness of treatment regimes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Moxifloxacin/Metronidazole or Piperacillin/TazobactamFor adult patients with intra-abdominal abscesses matching the criteria to be included will and enrolled in the study arm 1: Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily. |
| 2 | Active comparator | Drug: Moxifloxacin/Metronidazole or Piperacillin/TazobactamFor adult patients with intra-abdominal abscesses matching the criteria to be included will and enrolled in the study arm 2: Piperacillin / Tazobactam 4,5 g administered intravenously three times daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who attained full age (18 years) with intra-abdominal abscesses documented by:
- Laparotomy revealing intra-abdominal abscess or macroscopic gastrointestinal perforation OR
- Suspected intra-abdominal abscess and scheduled for operation with at least three of the following criteria:
- fever,
- leucocytosis,
Key exclusion criteria (24 listed)
- Patients with the following:
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 |
|---|---|---|
| Moxifloxacin/Metronidazole or Piperacillin/TazobactamAntibiotic therapy for patients with intra-abdominal abscesses; Intervention consists of antibiotic treatment of the patients with intraabdominal abscess with either the combination of Moxifloxacin and Metronidazole or Piperacillin/Tazobactam.1. Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily. 2. Piperacillin / Tazobactam 4,5 g administered intravenously three times daily. | Drug | 1, 2 |
Primary outcome
Clinical success / failure rate at the Test-of-Cure visit
Time frame: 14 days
clinical success
5 secondary outcomes
Clinical + Bacteriological response at End-of-Treatment-visit
Time frame: 14 days
Time to discharge from hospital
Time frame: up to several months
Course of disease on the basis of clinical and laboratory parameters
Time frame: several days
safety and tolerability of the study medication
Time frame: 4 to 10 days
cost effectiveness of treatment regimes
Time frame: up to several months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
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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.
Michael Winkler, Prof principal investigator
Medical School Hannover, Department for abdominal and transplant surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moxifloxacin/Metronidazole or Piperacillin/Tazobactam in people with Abscess, Intra-Abdominal, run by Hannover Medical School at 1 site in Germany.
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 8 inclusion and 24 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 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 success / failure rate at the Test-of-Cure visit (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2018.