Intra-abdominal InfectionsPhase 3NCT01473836
A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
A Phase 3 study testing Metronidazole and Ceftriaxone sodium in people with Intra-abdominal Infections, run by Pfizer at 15 sites in Japan.
Trial summary
The purpose of this study is to evaluate the clinical efficacy and safety in Japanese adult subjects with Intra-abdominal/Pelvic infections receiving Metronidazole IV 1,500-2,000 mg/day in combination with ceftriaxone sodium. Read more about this study
- Who is it for?
- Ages 16 to 79 years
- Conditions the study is for
- Intra-abdominal Infections
- What is being tested?
- Metronidazole and Ceftriaxone sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 15 sitesJapan
- Study dates
- Nov 2011to Oct 2012
- Phase
- Phase 3
- 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 16 to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16 years of age or older.
- Diagnosed with intra-abdominal infections or pelvic inflammatory diseases.
- Can be obtained a specimen for bacteriological efficacy assessment.
Who cannot join
- Known or suspected hypersensitivity, intolerance or contraindication to Metronidazole, Ceftriaxone sodium, or other cephem antibiotics.
- Severe renal dysfunction (creatinine clearance < 30 mL/min.) Reference: Cockcroft-Gault calculation formula.
- Hepatic dysfunction (AST, ALT, total bilirubin > 3 times upper limit of normal range values).
- Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Japan15 sites
National Hospital Organization Chiba Medical Center
Chiba, Chiba
National Hospital Organization Fukuyama Medical Center
Fukuyama, Hiroshima
Hirosaki National Hospital
Hirosaki, Aomori
Hitachi General Hospital
Hitachi, Ibaraki
Daiyukai First Hospital
Ichinomiya, Aichi-ken
Iida Municipal Hospital
Iida, Nagano
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka
Kawasaki Saiwai Hospital
Kawasaki, Kanagawa
National Hospital Organization Kokura Medical Center
Kitakyushu, Fukuoka
Koshigaya Municipal Hospital
Koshigaya, Saitama
Kumamoto Saishunso National Hospital
Koushi, Kumamoto
National Hospital Organization Kumamoto Medical Center
Kumamoto, Kumamoto
National Hospital Organization Nagasaki Medical Center
Ohmura, Nagasaki
National Hospital Organization Sendai Medical Center
Sendai, Miyagi
Nagano Prefectural Suzaka Hospital
Suzaka-shi, Nagano
About this study
Official title: A Phase 3, Multicenter, Unblind, Non-Comparative Study To Confirm Efficacy And Safety Of Intravenous Metronidazole In Patients With Intrabdominal Infection In Combination With Intravenous Ceftriaxone
The purpose of this study is to evaluate the clinical efficacy and safety in Japanese adult subjects with Intra-abdominal/Pelvic infections receiving Metronidazole IV 1,500-2,000 mg/day in combination with ceftriaxone sodium.
- Conditions
- Intra-abdominal Infections
- Being tested
- Metronidazole, Ceftriaxone sodium
- Keywords
- Metronidazole, intra-abdominal infection, pelvic inflammatory disease, anaerobe
- Medical subject headings
- Intraabdominal Infections, Pelvic Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) for 3 to 14 days, in principle. Treatment duration can be prolonged up to 21 days based on subject's condition.
Ceftriaxone sodiumDrug
Also called ROCEPHIN
Ceftriaxone sodium will be administered at a daily dose of 2 g (strength) when metronidazole is administered TID or at a daily dose of 4 g (strength) when metronidazole is administered QID.
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole | Experimental | Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) in combination with ceftriaxone sodium Receives: Drug: Metronidazole; Drug: Ceftriaxone sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response: Response Rate (Data Review Committee Assessment)
Clinical response was evaluated by the data review committee as effective (cured or improved), ineffective (not meeting "effective" criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; "number of participants evaluated as effective" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100.
Measured: Baseline to EOT (up to 14 days), TOC
Secondary outcomes (5)
Clinical Response: Response Rate (Investigator Assessment)
Clinical response was evaluated by the investigator as effective (cured or improved), ineffective (not meeting "effective" criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; "number of participants evaluated as effective" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100.
Measured: Baseline to EOT (up to 14 days), TOC
Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment)
The appropriateness of treatment continuation was evaluated on Day 4 by the investigator as continuation, discontinuation or indeterminate based on the clinical response. The percentage of participants was calculated from the following formula; "number of participants assessed as continuation" over "total number of participants that excluding ones assessed as indeterminate" multiplied by 100.
Measured: Baseline to Day 4
Bacteriological Response: Eradication Rate (Data Review Committee Assessment)
Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the data review committee, at Day 4, at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, "number of participants with bacteria eradication, presumed eradication or colonization" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100.
Measured: Baseline to Day 4, EOT (up to 14 days), TOC
Bacteriological Response: Eradication Rate (Investigator Assessment)
Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the investigator at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, "number of participants with bacteria eradication, presumed eradication or colonization" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100.
Measured: Baseline to Day 4, EOT (up to 14 days), TOC
Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole
Population pharmacokinetic analysis of Metronidazole is conducted by combining current study data with other Metronidazole studies.
Measured: Four samples were taken at any infusion after the first dosing: during infusion, immediately after end of infusion, between 15 and 60 minutes after end of infusion, and between 2 hours and immediately before the start of the next infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2012
- Study completionOct 2012
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 InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473836
- Sponsor's protocol ID
- A6831005
- Status last verified
- Dec 2013
- First submitted
- 11 Oct 2011
- Last updated
- 24 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mikamo H, Matsumizu M, Nakazuru Y, Nagashima M. Efficacy and safety of metronidazole injection for the treatment of infectious peritonitis, abdominal abscess and pelvic inflammatory diseases in Japan. J Infect Chemother. 2015 Feb;21(2):96-104. doi: 10.1016/j.jiac.2014.10.005. Epub 2014 Nov 28.
PubMed 25442806
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Unblind, Non-Comparative Study To Confirm Efficacy And Safety Of Intravenous Metronidazole In Patients With Intrabdominal Infection In Combination With Intravenous Ceftriaxone
- ClinicalTrials.gov ID
- NCT01473836
- Acronym / sponsor ID
- A6831005
- Conditions
- Intra-abdominal Infections
- Keywords
- Metronidazole, intra-abdominal infection, pelvic inflammatory disease, anaerobe
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Posted 10 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the clinical efficacy and safety in Japanese adult subjects with Intra-abdominal/Pelvic infections receiving Metronidazole IV 1,500-2,000 mg/day in combination with ceftriaxone sodium.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metronidazole | Experimental | Drug: Metronidazole, Drug: Ceftriaxone sodiumMetronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) in combination with ceftriaxone sodium |
Who may qualify
- Ages
- 16 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 16 years of age or older.
- Diagnosed with intra-abdominal infections or pelvic inflammatory diseases.
- Can be obtained a specimen for bacteriological efficacy assessment.
Key exclusion criteria (4 listed)
- Known or suspected hypersensitivity, intolerance or contraindication to Metronidazole, Ceftriaxone sodium, or other cephem antibiotics.
- Severe renal dysfunction (creatinine clearance < 30 mL/min.) Reference: Cockcroft-Gault calculation formula.
- Hepatic dysfunction (AST, ALT, total bilirubin > 3 times upper limit of normal range values).
- Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
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 |
|---|---|---|
| MetronidazoleMetronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) for 3 to 14 days, in principle. Treatment duration can be prolonged up to 21 days based on subject's condition. | Drug | Metronidazole |
| Ceftriaxone sodiumAlso: ROCEPHINCeftriaxone sodium will be administered at a daily dose of 2 g (strength) when metronidazole is administered TID or at a daily dose of 4 g (strength) when metronidazole is administered QID. | Drug | Metronidazole |
Primary outcome
Clinical Response: Response Rate (Data Review Committee Assessment)
Time frame: Baseline to EOT (up to 14 days), TOC
Clinical response was evaluated by the data review committee as effective (cured or improved), ineffective (not meeting "effective" criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; "number of participants evaluated as effective" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100.
5 secondary outcomes
Clinical Response: Response Rate (Investigator Assessment)
Time frame: Baseline to EOT (up to 14 days), TOC
Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment)
Time frame: Baseline to Day 4
Bacteriological Response: Eradication Rate (Data Review Committee Assessment)
Time frame: Baseline to Day 4, EOT (up to 14 days), TOC
Bacteriological Response: Eradication Rate (Investigator Assessment)
Time frame: Baseline to Day 4, EOT (up to 14 days), TOC
Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole
Time frame: Four samples were taken at any infusion after the first dosing: during infusion, immediately after end of infusion, between 15 and 60 minutes after end of infusion, and between 2 hours and immediately before the start of the next infusion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25442806Mikamo H, Matsumizu M, Nakazuru Y, Nagashima M. Efficacy and safety of metronidazole injection for the treatment of infectious peritonitis, abdominal abscess and pelvic inflammatory diseases in Japan. J Infect Chemother. 2015 Feb;21(2):96-104. doi: 10.1016/j.jiac.2014.10.005. Epub 2014 Nov 28.
- 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
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metronidazole and Ceftriaxone sodium in people with Intra-abdominal Infections, run by Pfizer at 15 sites in Japan.
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 4 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 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 10 Dec 2013). 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: Response Rate (Data Review Committee Assessment) (time frame: Baseline to EOT (up to 14 days), TOC). 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 NCT01473836, 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 24 Jan 2014.