Trial · NCT01591863

Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

NCT01591863, Phase 2, Completed, Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2015-03-17

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ConductScience Library. Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD). Trials, record NCT01591863. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01591863

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Trial

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

Title: Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
NCT number: NCT01591863
Status: Completed
Phases: Phase 2
Enrollment: 38 participants, actual
Lead sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions: Clostridium Difficile-associated Diarrhea
Interventions: fidaxomicin
First posted: 2012-05-04
Last updated: 2018-09-18
Results first posted: 2015-03-17

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events.	Enrollment through end of study (Day 38-41)	Number of participants with adverse events, as categorized by MedDRA.
Primary	Investigate Concentrations of Fidaxomicin in Plasma Samples.	3-5 hours after administration	3-5 hour plasma levels of fidaxomicin (mean)
Primary	Investigate Concentrations of Fidaxomicin in Fecal Samples.	End of Therapy; Day 10-11	End of therapy fecal levels of fidaxomicin (mean)
Primary	Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.	3-5 hours after administration	3-5 hour plasma levels of OP-1118 (mean)
Primary	Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.	End of Therapy; Day 10-11	End of therapy fecal levels of OP-1118 (mean)
Secondary	Evaluate the Clinical Outcome by Assessment of Clinical Response.	Day 10	Positive clinical response defined as resolution of diarrhea
Secondary	Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.	28 days post-treatment	Positive clinical response without recurrence through the follow-up period

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events.	Enrollment through end of study (Day 38-41)	Subjects receiving any amount of study drug	participants	NUMBER
PRIMARY	Investigate Concentrations of Fidaxomicin in Plasma Samples.	3-5 hours after administration	Treated subjects with evaluable plasma pharmacokinetic data	ng/mL	MEAN
PRIMARY	Investigate Concentrations of Fidaxomicin in Fecal Samples.	End of Therapy; Day 10-11	Treated subjects with evaluable fecal data	microgram/g	MEAN
SECONDARY	Evaluate the Clinical Outcome by Assessment of Clinical Response.	Day 10	Treated subjects with positive toxin assay result within 24 hours of enrollment	percentage of subjects	NUMBER
SECONDARY	Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.	28 days post-treatment	Treated subjects with positive toxin assay result within 24 hours of enrollment	percentage of participants	NUMBER
PRIMARY	Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.	3-5 hours after administration	Treated subjects with evaluable plasma pharmacokinetic data	ng/mL	MEAN
PRIMARY	Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.	End of Therapy; Day 10-11	Treated subjects with evaluable fecal data	microgram/g	MEAN

Source ClinicalTrials.gov

Results by group7

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

Outcome	Group	Value	Spread	Units
Number of Participants With Adverse Events.	Fidaxomicin	28		participants
Investigate Concentrations of Fidaxomicin in Plasma Samples.	Fidaxomicin	13.363	Standard Deviation 15.472	ng/mL
Investigate Concentrations of Fidaxomicin in Fecal Samples.	Fidaxomicin	3227.93	Standard Deviation 2668.08	microgram/g
Evaluate the Clinical Outcome by Assessment of Clinical Response.	Fidaxomicin	92.1	95% Confidence Interval 83.5 to 100	percentage of subjects
Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.	Fidaxomicin	65.8	95% Confidence Interval 50.7 to 80.9	percentage of participants
Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.	Fidaxomicin	60.016	Standard Deviation 152.196	ng/mL
Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.	Fidaxomicin	865.49	Standard Deviation 614.15	microgram/g

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Fidaxomicin	38
Overall Study	COMPLETED	Fidaxomicin	24
Overall Study	NOT COMPLETED	Fidaxomicin	14

Source ClinicalTrials.gov

Adverse events22

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	abdominal pain upper	Gastrointestinal disorders	Fidaxomicin	3	38
other	constipation	Gastrointestinal disorders	Fidaxomicin	2	38
other	diarrhea	Gastrointestinal disorders	Fidaxomicin	2	38
other	nausea	Gastrointestinal disorders	Fidaxomicin	2	38
other	oesophagitis	Gastrointestinal disorders	Fidaxomicin	2	38
other	vomiting	Gastrointestinal disorders	Fidaxomicin	3	38
other	chest pain	General disorders	Fidaxomicin	2	38
other	pyrexia	General disorders	Fidaxomicin	4	38
other	nasopharyngitis	Infections and infestations	Fidaxomicin	2	38
other	dehydration	Metabolism and nutrition disorders	Fidaxomicin	2	38

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fidaxomicin
Total, other adverse events	Fidaxomicin	17	38
Total, serious adverse events	Fidaxomicin	9	38

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28575523	RESULT

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 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/NCT01591863

GET https://conductscience.org/api/trials/v1/NCT01591863/events?page=2

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