Back to resultsEfficacy and Safety of Teicoplanin in CDAD
Primary Purpose
Clostridium Difficile Infection-associated Diarrhea and Colitis
Status
Terminated
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
TEICOPLANIN
Sponsored by
About this trial
This is an interventional treatment trial for Clostridium Difficile Infection-associated Diarrhea and Colitis
Eligibility Criteria
Inclusion criteria :
- Signed Informed Consent.
- Male or female no less than 18 years of age.
- Inpatient with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with: Diarrhea: a change in bowel habits with > 3 liquid or unformed bowel movements (UBM) within 24 hours prior to enrollment, AND Positive C. difficile toxin test on a stool sample produced within 72 hours prior to enrollment.
Exclusion criteria:
- More than one previous episode of CDAD in the 3-month period prior to enrollment.
- Evidence of life-threatening or fulminant CDAD.
- Likelihood of death within 72 hours from any cause.
- History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea
- Antimicrobial treatment active against CDAD administered for > 24 hours except for metronidazole treatment failures (MTF).
- Known hypersensitivity or contraindication to teicoplanin.
- Pregnant or nursing females.
- Unable or unwilling to comply with all protocol requirements.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- investigational site CHINA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Teicoplanin
Arm Description
teicoplanin, administered orally 100-200 mg, twice a day
Outcomes
Primary Outcome Measures
Clinical cure rate
Clinical cure is defined as: Resolution of diarrhea (ROD) (≤ 3 unformed bowel movement (UBM) per day for at least 2 consecutive days) on study treatment and maintained for 2 days after End of treatment (EOT), AND No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant (FMT) between first dose of study drug and 2 days after EOT (inclusive)
Recurrence rate
Recurrence is defined as reappearance of diarrhea during the 8-week follow-up period.
Time to resolution of diarrhea
Resolution of diarrhea (ROD) (≤ 3 unformed bowel movement (UBM) per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end of treatment.
Secondary Outcome Measures
Incidence of nephrotoxicity
Nephrotoxicity is defined as: serum creatinine increase of more than 0.5 mg/dL if the baseline serum creatinine was ≤ 3 mg/dL or a rise of > 1 mg/dL if the initial serum creatinine was > 3 mg/dL; or 50% increase from baseline; or a drop in calculated creatinine clearance using Cockroft-Gault formula of ≥ 50% from baseline.
Incidence of hepatotoxicit
Hepatotoxicity is defined as: AST or ALT 3 times upper limit of normal or if AST or ALT baseline is abnormal, AST or ALT increase of ≥ 3 times the baseline and adverse events/ reactions using the MedDRA SMQ (Standardised MedDRA Query) "Hepatic Disorders".
Incidence of thrombocytopenia
Thrombocytopenia is defined as: platelets < 100 000/mm3 or < 100 Giga/L
Incidence of hearing and balance/vestibular disorders
Hearing and balance/vestibular disorders are defined as: identified via PT terms using MedDRA SMQ for "hearing and vestibular disorders" (narrow) and additionally the PT "balance disorder".
Additional renal endpoints: renal failure, dialysis and renal replacement therapy
Any untoward adverse events/reactions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04003818
Brief Title
Efficacy and Safety of Teicoplanin in CDAD
Official Title
Prospective, Interventional, Phase IV Study, Evaluating the Efficacy and Safety of Teicoplanin (100-200 mg, Administered Orally Twice a Day) in Patients With Clostridium Difficile Infection-associated Diarrhea and Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID-19 and great challenges during patient enrolment period, current status of this study is far behind the plan. The study cannot be completed according to the plan. Sanofi decides to terminate the study upon comprehensive assessment.
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
January 21, 2021 (Actual)
Study Completion Date
March 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary Objective:
Explore the efficacy of teicoplanin (100-200 mg administered orally twice a day for 7 to 14 days) in patients with Clostridium difficile infection-associated diarrhea and colitis
Secondary Objective:
Evaluate the safety of teicoplanin in patients with Clostridium difficile infection-associated diarrhea and colitis
Detailed Description
Approximate 10 weeks
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection-associated Diarrhea and Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teicoplanin
Arm Type
Experimental
Arm Description
teicoplanin, administered orally 100-200 mg, twice a day
Intervention Type
Drug
Intervention Name(s)
TEICOPLANIN
Intervention Description
Pharmaceutical form:solution for oral administration Route of administration: oral
Primary Outcome Measure Information:
Title
Clinical cure rate
Description
Clinical cure is defined as: Resolution of diarrhea (ROD) (≤ 3 unformed bowel movement (UBM) per day for at least 2 consecutive days) on study treatment and maintained for 2 days after End of treatment (EOT), AND No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant (FMT) between first dose of study drug and 2 days after EOT (inclusive)
Time Frame
2 days after 7-14 days treatment
Title
Recurrence rate
Description
Recurrence is defined as reappearance of diarrhea during the 8-week follow-up period.
Time Frame
Up to 10 weeks
Title
Time to resolution of diarrhea
Description
Resolution of diarrhea (ROD) (≤ 3 unformed bowel movement (UBM) per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end of treatment.
Time Frame
Up to 10 weeks
Secondary Outcome Measure Information:
Title
Incidence of nephrotoxicity
Description
Nephrotoxicity is defined as: serum creatinine increase of more than 0.5 mg/dL if the baseline serum creatinine was ≤ 3 mg/dL or a rise of > 1 mg/dL if the initial serum creatinine was > 3 mg/dL; or 50% increase from baseline; or a drop in calculated creatinine clearance using Cockroft-Gault formula of ≥ 50% from baseline.
Time Frame
Until 10 weeks
Title
Incidence of hepatotoxicit
Description
Hepatotoxicity is defined as: AST or ALT 3 times upper limit of normal or if AST or ALT baseline is abnormal, AST or ALT increase of ≥ 3 times the baseline and adverse events/ reactions using the MedDRA SMQ (Standardised MedDRA Query) "Hepatic Disorders".
Time Frame
Up to 10 weeks
Title
Incidence of thrombocytopenia
Description
Thrombocytopenia is defined as: platelets < 100 000/mm3 or < 100 Giga/L
Time Frame
Up to 10 weeks
Title
Incidence of hearing and balance/vestibular disorders
Description
Hearing and balance/vestibular disorders are defined as: identified via PT terms using MedDRA SMQ for "hearing and vestibular disorders" (narrow) and additionally the PT "balance disorder".
Time Frame
Up to 10 weeks
Title
Additional renal endpoints: renal failure, dialysis and renal replacement therapy
Time Frame
Until 10 weeks
Title
Any untoward adverse events/reactions
Time Frame
Up to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
Signed Informed Consent.
Male or female no less than 18 years of age.
Inpatient with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with: Diarrhea: a change in bowel habits with > 3 liquid or unformed bowel movements (UBM) within 24 hours prior to enrollment, AND Positive C. difficile toxin test on a stool sample produced within 72 hours prior to enrollment.
Exclusion criteria:
More than one previous episode of CDAD in the 3-month period prior to enrollment.
Evidence of life-threatening or fulminant CDAD.
Likelihood of death within 72 hours from any cause.
History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea
Antimicrobial treatment active against CDAD administered for > 24 hours except for metronidazole treatment failures (MTF).
Known hypersensitivity or contraindication to teicoplanin.
Pregnant or nursing females.
Unable or unwilling to comply with all protocol requirements.
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
investigational site CHINA
City
China
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
Efficacy and Safety of Teicoplanin in CDAD
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