Intra-abdominal InfectionPhase 4NCT00952796
A Comparative Study of Ampicillin/Sulbactam Versus Moxifloxacin in the Treatment of Complicated Intra-abdominal Infections
A Phase 4 study testing moxifloxacin and ampicillin/sulbactam in people with Intra-abdominal Infection, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
On the basis of monotherapy for intra-abdominal infection, the investigators are conducting this study to identify the difference of drug efficacy between ampicillin/sulbactam and moxifloxacin. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intra-abdominal Infection
- What is being tested?
- moxifloxacin and ampicillin/sulbactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Dec 2010
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients diagnosed of complicated intra-abdominal infection need surgical treatment
Who cannot join
- patients diagnosed of intra-abdominal infection receive non-operative management
- patients with known allergic history of fluoroquinolone
- Severe, life threatening disease with a life expectancy of < 48 h or APS and APACHE scores of > 35
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Hospital, Department of Emergency Medicine/Surgery
Kaohsiung, Taiwan, 804
About this study
On the basis of monotherapy for intra-abdominal infection, the investigators are conducting this study to identify the difference of drug efficacy between ampicillin/sulbactam and moxifloxacin.
- Conditions
- Intra-abdominal Infection
- Being tested
- moxifloxacin, ampicillin/sulbactam
- Keywords
- intra-abdominal infection, moxifloxacin, ampicillin/sulbactam
- Medical subject headings
- Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moxifloxacinDrug
moxifloxacin 400mg once daily (IV form, 60minutes)
ampicillin/sulbactamDrug
ampicillin/sulbactam 1.5g 4 times daily (IV form, administered 60minutes)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patients with intra-abdominal infection treated with moxifloxacin 400mg once daily Receives: Drug: moxifloxacin |
| 2 | Active comparator | patients with intra-abdominal infection treated with ampicillin/sulbactam 1.5g 4 times daily Receives: Drug: ampicillin/sulbactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical response at test-of-cure visit
Measured: test of cure: 10-14 days after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-abdominal InfectionStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952796
- Sponsor's protocol ID
- KMU-IRB-970389
- Status last verified
- Jan 2009
- First submitted
- 1 Mar 2009
- Last updated
- 2 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Ampicillin/Sulbactam Versus Moxifloxacin in the Treatment of Complicated Intra-abdominal Infections
- ClinicalTrials.gov ID
- NCT00952796
- Acronym / sponsor ID
- KMU-IRB-970389
- Conditions
- Intra-abdominal Infection
- Keywords
- intra-abdominal infection, moxifloxacin, ampicillin/sulbactam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Aug 2009 (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.
On the basis of monotherapy for intra-abdominal infection, the investigators are conducting this study to identify the difference of drug efficacy between ampicillin/sulbactam and moxifloxacin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: moxifloxacinpatients with intra-abdominal infection treated with moxifloxacin 400mg once daily |
| 2 | Active comparator | Drug: ampicillin/sulbactampatients with intra-abdominal infection treated with ampicillin/sulbactam 1.5g 4 times daily |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed of complicated intra-abdominal infection need surgical treatment
Key exclusion criteria (3 listed)
- patients diagnosed of intra-abdominal infection receive non-operative management
- patients with known allergic history of fluoroquinolone
- Severe, life threatening disease with a life expectancy of < 48 h or APS and APACHE scores of > 35
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 |
|---|---|---|
| moxifloxacinmoxifloxacin 400mg once daily (IV form, 60minutes) | Drug | 1 |
| ampicillin/sulbactamampicillin/sulbactam 1.5g 4 times daily (IV form, administered 60minutes) | Drug | 2 |
Primary outcome
clinical response at test-of-cure visit
Time frame: test of cure: 10-14 days after initial treatment
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 2 Aug 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing moxifloxacin and ampicillin/sulbactam in people with Intra-abdominal Infection, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 1 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 2 Aug 2011. 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 Taiwan. 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?
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 response at test-of-cure visit (time frame: test of cure: 10-14 days after initial treatment). 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 2 Aug 2011.