Trial · NCT01597973

Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME)

NCT01597973, Phase 3, Completed, University of Michigan; results first posted 2021-11-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME). Trials, record NCT01597973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01597973

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Trial

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

Title: Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME)
NCT number: NCT01597973
Status: Completed
Phases: Phase 3
Enrollment: 467 participants, actual
Lead sponsor: University of Michigan
Conditions: Pneumonia, Blood Stream Infection
Interventions: colistin and meropenem, colistin and placebo
First posted: 2012-05-15
Last updated: 2022-11-14
Results first posted: 2021-11-30

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Mortality	participants will be followed daily for the duration of hospital stay, an expected average of 4 weeks	Determine whether the treatment regimen of colistin combined with a carbapenem (imipenem or meropenem) is associated with a decreased risk for all-cause mortality during the 30 day post-enrollment period compared to colistin combined with a placebo for subjects with bloodstream infection (BSI) and/or pneumonia due to extensively drug-resistant Gram-negative bacilli (XDR-GNB).
Secondary	Number of Participants Who Develop Colistin Resistance	patients' resistance data will be collected up to 30 days	Determine what treatment regimen (colistin monotherapy (combined with placebo)) or colistin combined a carbapenem (imipenem or meropenem) is more likely to reduce the frequency of emergence of colistin resistance among XDR-GNB isolates during therapy. Measurements of Minimum Inhibitory Concentration of colistin to XDR-GNB. This is shown below as numbers of those subjects who develop colistin resistance and their percentages of the total completed population.
Secondary	Clinical Failure at the End of Therapy	48 hours after end of treatment, that is up to 16 days	Clinical failure as defined by either Blood Stream Infection (BSI) or Pneumonia; based on death between 48 hours and end of treatment, medication change from protocol, a positive blood culture after 5 days of blood stream infection treatment, or no improvements in PaO2/FiO2 at end of treatment.
Secondary	Microbiologic Cure at the End of Therapy	From 5 days after enrollment up to 14 days following enrollment (i.e. end of treatment)	Microbiologic cure at the end of therapy as defined by the number of participants who no longer have the causative XDR-GNB pathogens for their BSI or pneumonia identified based on microbiologic testing
Secondary	Number of Participants With Toxicities Related to Treatment Medications	Up to 16 days	Frequency is shown for each of the following: Nephrotoxicity, Hepatotoxicity, Seizures, Neurotoxicity, Hypersensitivity reaction

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mortality	participants will be followed daily for the duration of hospital stay, an expected average of 4 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Develop Colistin Resistance	patients' resistance data will be collected up to 30 days	Follow up cultures were unable to be obtained for some subjects. Therefore emergence of resistance status for those subjects could not be determined.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical Failure at the End of Therapy	48 hours after end of treatment, that is up to 16 days	54 patients were omitted due to death before 48 hours (n=40) or incomplete PaO2/FiO2 data (n=14).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Microbiologic Cure at the End of Therapy	From 5 days after enrollment up to 14 days following enrollment (i.e. end of treatment)	Some patients did not have data in the time window of interest (from 5 days following enrollment until end of treatment, 14 days) (e.g. from some specimens not being produced or available).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Toxicities Related to Treatment Medications	Up to 16 days	Follow up creatinine clearance data was missing from many patients resulting in a smaller analysis population for nephrotoxicity.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group22

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

Outcome	Group	Category	Value	Units
Mortality	Colistin and Placebo	Dead	92	Participants
Mortality	Colistin and a Carbapenem	Dead	78	Participants
Mortality	Colistin and Placebo	Alive	122	Participants
Mortality	Colistin and a Carbapenem	Alive	133	Participants
Number of Participants Who Develop Colistin Resistance	Colistin and Placebo		18	Participants
Number of Participants Who Develop Colistin Resistance	Colistin and a Carbapenem		15	Participants
Clinical Failure at the End of Therapy	Colistin and Placebo		115	Participants
Clinical Failure at the End of Therapy	Colistin and a Carbapenem		97	Participants
Microbiologic Cure at the End of Therapy	Colistin and Placebo	Cure	112	Participants
Microbiologic Cure at the End of Therapy	Colistin and a Carbapenem	Cure	105	Participants

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Colistin and Placebo	234
Overall Study	STARTED	Colistin and a Carbapenem	230
Overall Study	Began First Dose	Colistin and Placebo	230
Overall Study	Began First Dose	Colistin and a Carbapenem	228
Overall Study	COMPLETED	Colistin and Placebo	214
Overall Study	COMPLETED	Colistin and a Carbapenem	211
Overall Study	NOT COMPLETED	Colistin and Placebo	20
Overall Study	NOT COMPLETED	Colistin and a Carbapenem	19

Source ClinicalTrials.gov

Adverse events818

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
other	ALT increased	Investigations	Colistin and Placebo	3	230
other	ALT increased	Investigations	Colistin and a Carbapenem	7	228
other	APTT increased	Investigations	Colistin and Placebo	0	230
other	APTT increased	Investigations	Colistin and a Carbapenem	1	228
other	AST increased	Investigations	Colistin and Placebo	2	230
other	AST increased	Investigations	Colistin and a Carbapenem	2	228
other	AV block first degree	Cardiac disorders	Colistin and Placebo	0	230
other	AV block first degree	Cardiac disorders	Colistin and a Carbapenem	1	228
other	Abdominal distension	Gastrointestinal disorders	Colistin and Placebo	1	230
other	Abdominal distension	Gastrointestinal disorders	Colistin and a Carbapenem	2	228

1 to 10 of 818Source ClinicalTrials.gov

See all 818 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Colistin and Placebo	98	230
Total, all-cause mortality	Colistin and a Carbapenem	85	228
Total, other adverse events	Colistin and Placebo	169	230
Total, other adverse events	Colistin and a Carbapenem	161	228
Total, serious adverse events	Colistin and Placebo	13	230
Total, serious adverse events	Colistin and a Carbapenem	10	228

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37538951	DERIVED

Source PubMed

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 comparisons4

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

Comparison	Source
Colistin and Placebo vs Colistin and a Carbapenem: Number of Participants Who Develop Colistin Resistance	Trial comparisons
Colistin and Placebo vs Colistin and a Carbapenem: Clinical Failure at the End of Therapy	Trial comparisons
Colistin and Placebo vs Colistin and a Carbapenem: deaths from any cause	Trial comparisons
Colistin and Placebo vs Colistin and a Carbapenem: serious adverse events	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.

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.

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