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Trial · NCT01561794

A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia

NCT01561794, Phase 3, Completed, Bayer

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia. Trials, record NCT01561794. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01561794

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia
NCT number
NCT01561794
Status
Completed
Phases
Phase 3
Enrollment
44 participants, actual
Lead sponsor
Bayer
Conditions
Pneumonia
Interventions
Ciprofloxacin (Cipro, BAYQ3939)
First posted
2012-03-23
Last updated
2015-04-27

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySafety variables will be summarized using descriptive statistics based on adverse events collectionUp to 30 (±5) days after the end of treatment
PrimaryAUC (Area under the blood concentration/time curve)Within 0-24 hours and 48-72 hours after the first study drug administration
PrimaryCmax (Maximum observed concentration)Within 0-24 hours and 48-72 hours after the first study drug administration
PrimaryAUC/MIC (Minimum inhibitory concentration)Within 0-24 hours and 48-72 hours after the first study drug administration
PrimaryCmax/MICWithin 0-24 hours and 48-72 hours after the first study drug administration
PrimaryAUC/MPC (Mutant prevention concentration)Within 0-24 hours and 48-72 hours after the first study drug administration
PrimaryCmax/MPCWithin 0-24 hours and 48-72 hours after the first study drug administration
SecondaryClinical response rate based on resolution of signs and symptomsUp to 13 days after the first study drug administration
SecondaryMicrobiological response rate, assessed as eradication rate based on microbiologically evaluable patientsUp to 23 days after the first study drug administration
SecondaryTest of cure rate based on resolution of signs, symptoms, and the clinical responseUp to 23 days after the first study drug administration

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT01561794

GET https://conductscience.org/api/trials/v1/NCT01561794/registered