CompletedPhase 2

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

38 participantsStarted 2012-06-15

Plain-language summary

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).

Who can participate

Age range

6 Months – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female 6 months to 17 years 11 months of age, inclusive; * Female subjects of childbearing potential must use adequate contraception * Diagnosed with CDAD Exclusion Criteria: * Concurrent use of oral vancomycin or metronidazole or any other effective treatments for CDAD * Fulminant colitis * History of inflammatory bowel disease * Pregnant or breast-feeding * Need for concurrent use of some P-glycoprotein inhibitors during therapy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Adverse Events.

Timeframe: Enrollment through end of study (Day 38-41)

Investigate Concentrations of Fidaxomicin in Plasma Samples.

Timeframe: 3-5 hours after administration

Investigate Concentrations of Fidaxomicin in Fecal Samples.

Timeframe: End of Therapy; Day 10-11

Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.

Timeframe: 3-5 hours after administration

Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.

Timeframe: End of Therapy; Day 10-11

Trial details

NCT IDNCT01591863

SponsorOptimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-03-07

Results submitted2015-03-05

View on ClinicalTrials.gov More Clostridium Difficile-associated Diarrhea trials

Who can participate

Age range

6 Months – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Adverse Events.

Timeframe: Enrollment through end of study (Day 38-41)

Investigate Concentrations of Fidaxomicin in Plasma Samples.

Timeframe: 3-5 hours after administration

Investigate Concentrations of Fidaxomicin in Fecal Samples.

Timeframe: End of Therapy; Day 10-11

Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.

Timeframe: 3-5 hours after administration

Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.

Timeframe: End of Therapy; Day 10-11