Clostridium Difficile-associated DiarrheaPhase 2NCT01591863
Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
A Phase 2 study testing fidaxomicin in people with Clostridium Difficile-associated Diarrhea, run by Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
Trial 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). Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Clostridium Difficile-associated Diarrhea
- What is being tested?
- fidaxomicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2012to 7 Mar 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Phase 2A, Multi-Center, Open-Label, Uncontrolled Study to Determine the Safety, Tolerability, and Pharmacokinetics of Fidaxomicin Oral Suspension or Tablets in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).
- Being tested
- fidaxomicin
- Keywords
- Clostridium difficile-associated diarrhea, CDAD, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fidaxomicinDrug
Also called Dificid, Dificlir, OPT-80, PAR-101
6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.
6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| fidaxomicin | Experimental | Not described Receives: Drug: fidaxomicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events.
Number of participants with adverse events, as categorized by MedDRA.
Measured: Enrollment through end of study (Day 38-41)
Investigate Concentrations of Fidaxomicin in Plasma Samples.
3-5 hour plasma levels of fidaxomicin (mean)
Measured: 3-5 hours after administration
Investigate Concentrations of Fidaxomicin in Fecal Samples.
End of therapy fecal levels of fidaxomicin (mean)
Measured: End of Therapy; Day 10-11
Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.
3-5 hour plasma levels of OP-1118 (mean)
Measured: 3-5 hours after administration
Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.
End of therapy fecal levels of OP-1118 (mean)
Measured: End of Therapy; Day 10-11
Secondary outcomes (2)
Evaluate the Clinical Outcome by Assessment of Clinical Response.
Positive clinical response defined as resolution of diarrhea
Measured: Day 10
Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.
Positive clinical response without recurrence through the follow-up period
Measured: 28 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study start15 Jun 2012
- Primary completion7 Mar 2014
- Study completion7 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile-associated DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591863
- Sponsor's protocol ID
- 5119-010
- Other IDs
- OPT-80-206
- Status last verified
- Aug 2018
- First submitted
- 27 Apr 2012
- Last updated
- 18 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
O'Gorman MA, Michaels MG, Kaplan SL, Otley A, Kociolek LK, Hoffenberg EJ, Kim KS, Nachman S, Pfefferkorn MD, Sentongo T, Sullivan JE, Sears P. Safety and Pharmacokinetic Study of Fidaxomicin in Children With Clostridium difficile-Associated Diarrhea: A Phase 2a Multicenter Clinical Trial. J Pediatric Infect Dis Soc. 2018 Aug 17;7(3):210-218. doi: 10.1093/jpids/pix037.
PubMed 28575523
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A, Multi-Center, Open-Label, Uncontrolled Study to Determine the Safety, Tolerability, and Pharmacokinetics of Fidaxomicin Oral Suspension or Tablets in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
- ClinicalTrials.gov ID
- NCT01591863
- Acronym / sponsor ID
- 5119-010
- Keywords
- Clostridium difficile-associated diarrhea, CDAD, Pediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2012 (actual)
- Primary completion
- 7 Mar 2014 (actual)
- Study completion
- 7 Mar 2014 (actual)
- First posted
- 4 May 2012 (estimated)
- Results
- Posted 17 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fidaxomicin | Experimental | Drug: fidaxomicin |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fidaxomicinAlso: Dificid, Dificlir, OPT-80, PAR-1016 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days. 6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days. | Drug | fidaxomicin |
Primary outcome
Number of Participants With Adverse Events.
Time frame: Enrollment through end of study (Day 38-41)
Number of participants with adverse events, as categorized by MedDRA.
Investigate Concentrations of Fidaxomicin in Plasma Samples.
Time frame: 3-5 hours after administration
3-5 hour plasma levels of fidaxomicin (mean)
Investigate Concentrations of Fidaxomicin in Fecal Samples.
Time frame: End of Therapy; Day 10-11
End of therapy fecal levels of fidaxomicin (mean)
Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.
Time frame: 3-5 hours after administration
3-5 hour plasma levels of OP-1118 (mean)
Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.
Time frame: End of Therapy; Day 10-11
End of therapy fecal levels of OP-1118 (mean)
2 secondary outcomes
Evaluate the Clinical Outcome by Assessment of Clinical Response.
Time frame: Day 10
Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.
Time frame: 28 days post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28575523O'Gorman MA, Michaels MG, Kaplan SL, Otley A, Kociolek LK, Hoffenberg EJ, Kim KS, Nachman S, Pfefferkorn MD, Sentongo T, Sullivan JE, Sears P. Safety and Pharmacokinetic Study of Fidaxomicin in Children With Clostridium difficile-Associated Diarrhea: A Phase 2a Multicenter Clinical Trial. J Pediatric Infect Dis Soc. 2018 Aug 17;7(3):210-218. doi: 10.1093/jpids/pix037.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fidaxomicin in people with Clostridium Difficile-associated Diarrhea, run by Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events. (time frame: Enrollment through end of study (Day 38-41)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01591863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.