Trial · NCT00402727
Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection
NCT00402727, Phase 3, Completed, Bayer; results first posted 2010-01-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection. Trials, record NCT00402727. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00402727
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection
- NCT number
- NCT00402727
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 813 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Abscess, Wound Infection, Diabetic Foot, Ulcer
- Interventions
- Moxifloxacin (Avelox, BAY12-8039), Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid
- First posted
- 2006-11-22
- Last updated
- 2014-11-07
- Other registries' IDs
- eudract:2006-001599-18
- Results first posted
- 2010-01-11
- Limitations and caveats
Ten patients (six from the moxifloxacin group and 4 from the comparator group) did not receive study medication. They were excluded from the safety analyses. No adverse events were reported in these patients.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population | 14 - 28 days after last dose of study medication | Clinical response was evaluated by the DRC and graded as "cure", "failure" or "indeterminate" at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs. |
| Secondary | Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population | 14 - 28 days after last dose of study medication | Clinical response was evaluated by the DRC and graded as "cure", "failure" or "indeterminate" at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs. |
| Secondary | Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Per Protocol (PP) Population | 3 - 5 days after start of treatment | Clinical response was evaluated by the investigator and graded as "improvement in signs and symptoms," or "failure to respond," or "indeterminate" at Day 3 to 5 after treatment start based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs. |
| Secondary | Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Intent to Treat (ITT) Population | 3 - 5 days after start of treatment | Clinical response was evaluated by the investigator and graded as "improvement in signs and symptoms," or "failure to respond," or "indeterminate" at Day 3 to 5 after treatment start based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs |
| Secondary | Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population | after 7 - 21 days of treatment | Clinical response was evaluated by the investigator and graded as "resolution," or "failure to respond," or "indeterminate" at the end of therapy based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs. |
| Secondary | Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Intent to Treat (ITT) Population | after 7 - 21 days of treatment | Clinical response was evaluated by the investigator and graded as "resolution", or "failure to respond," or "indeterminate" at the end of therapy based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs. |
| Secondary | Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the ITT Population With Causative Organisms | 3 - 5 days after start of treatment | Bacteriological success was defined as presumed eradication or eradication without superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, superinfection as appearance of a new organism. |
| Secondary | Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the Microbiological Valid (MBV) Population | 3 - 5 days after start of treatment | Bacteriological success was defined as presumed eradication or eradication without superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, superinfection as appearance of a new organism. |
| Secondary | Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the ITT Population With Causative Organisms | after 7 - 21 days of treatment | Bacteriological success is presumed eradication or eradication without recurrence or superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study, superinfection as appearance of a new organism. |
| Secondary | Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the Microbiological Valid (MBV) Population | after 7 - 21 days of treatment | Bacteriological success is presumed eradication or eradication without recurrence or superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study, superinfection as appearance of a new organism. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population | 14 - 28 days after last dose of study medication | The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population | 14 - 28 days after last dose of study medication | The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as all randomized subject that received at least one dose of study medication and had at least one observation after intake of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Per Protocol (PP) Population | 3 - 5 days after start of treatment | The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Intent to Treat (ITT) Population | 3 - 5 days after start of treatment | The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the secondary outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population | after 7 - 21 days of treatment | The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Intent to Treat (ITT) Population | after 7 - 21 days of treatment | The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the secondary outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the ITT Population With Causative Organisms | 3 - 5 days after start of treatment | The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the Microbiological Valid (MBV) Population | 3 - 5 days after start of treatment | Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from indeterminate. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the ITT Population With Causative Organisms | after 7 - 21 days of treatment | The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the Microbiological Valid (MBV) Population | after 7 - 21 days of treatment | Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from indeterminate. | percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population | Moxifloxacin | 88.6 | percentage of participants | ||
| Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population | PIP/TAZ-AMC | 89.6 | percentage of participants | ||
| Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population | Moxifloxacin | 82.2 | percentage of participants | ||
| Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population | PIP/TAZ-AMC | 80.9 | percentage of participants | ||
| Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Per Protocol (PP) Population | Moxifloxacin | 98.3 | percentage of participants | ||
| Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Per Protocol (PP) Population | PIP/TAZ-AMC | 99.0 | percentage of participants | ||
| Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Intent to Treat (ITT) Population | Moxifloxacin | 97.2 | percentage of participants | ||
| Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Intent to Treat (ITT) Population | PIP/TAZ-AMC | 95.8 | percentage of participants | ||
| Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population | Moxifloxacin | 95.3 | percentage of participants | ||
| Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population | PIP/TAZ-AMC | 95.1 | percentage of participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Moxifloxacin | 432 | |
| Overall Study | STARTED | PIP/TAZ-AMC | 381 | |
| Overall Study | Achieving End Of Treatment (EOT) | Moxifloxacin | 408 | |
| Overall Study | Achieving End Of Treatment (EOT) | PIP/TAZ-AMC | 355 | |
| Overall Study | Achieving Test Of Cure (TOC) | Moxifloxacin | 390 | |
| Overall Study | Achieving Test Of Cure (TOC) | PIP/TAZ-AMC | 347 | |
| Overall Study | COMPLETED | Moxifloxacin | 390 | |
| Overall Study | COMPLETED | PIP/TAZ-AMC | 347 | |
| Overall Study | NOT COMPLETED | Moxifloxacin | 42 | |
| Overall Study | NOT COMPLETED | PIP/TAZ-AMC | 34 |
Source ClinicalTrials.gov
Adverse events82
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Moxifloxacin | 10 | 426 | |
| other | Diarrhoea | Gastrointestinal disorders | PIP/TAZ-AMC | 8 | 377 | |
| other | Nausea | Gastrointestinal disorders | Moxifloxacin | 5 | 426 | |
| other | Nausea | Gastrointestinal disorders | PIP/TAZ-AMC | 3 | 377 | |
| other | Pyrexia | General disorders | Moxifloxacin | 7 | 426 | |
| other | Pyrexia | General disorders | PIP/TAZ-AMC | 3 | 377 | |
| other | Electrocardiogram QT prolonged | Investigations | Moxifloxacin | 1 | 426 | |
| other | Electrocardiogram QT prolonged | Investigations | PIP/TAZ-AMC | 5 | 377 | |
| other | Headache | Nervous system disorders | Moxifloxacin | 5 | 426 | |
| other | Headache | Nervous system disorders | PIP/TAZ-AMC | 3 | 377 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Moxifloxacin | ||
| Total, all-cause mortality | PIP/TAZ-AMC | ||
| Total, other adverse events | Moxifloxacin | 35 | 426 |
| Total, other adverse events | PIP/TAZ-AMC | 20 | 377 |
| Total, serious adverse events | Moxifloxacin | 21 | 426 |
| Total, serious adverse events | PIP/TAZ-AMC | 14 | 377 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Moxifloxacin vs PIP/TAZ-AMC: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00402727
GET https://conductscience.org/api/trials/v1/NCT00402727/results?page=2