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Efficacy and Safety of Teicoplanin in CDAD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003818
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

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


Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection-associated Diarrhea and Colitis Drug: TEICOPLANIN Phase 4

Detailed Description:
Approximate 10 weeks

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 15, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Teicoplanin
teicoplanin, administered orally 100-200 mg, twice a day
Drug: TEICOPLANIN
Pharmaceutical form:solution for oral administration Route of administration: oral




Primary Outcome Measures :
  1. Clinical cure rate [ Time Frame: 2 days after 7-14 days treatment ]
    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)

  2. Recurrence rate [ Time Frame: Up to 10 weeks ]
    Recurrence is defined as reappearance of diarrhea during the 8-week follow-up period.

  3. Time to resolution of diarrhea [ Time Frame: Up to 10 weeks ]
    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 :
  1. Incidence of nephrotoxicity [ Time Frame: Until 10 weeks ]
    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.

  2. Incidence of hepatotoxicit [ Time Frame: Up to 10 weeks ]
    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".

  3. Incidence of thrombocytopenia [ Time Frame: Up to 10 weeks ]
    Thrombocytopenia is defined as: platelets < 100 000/mm3 or < 100 Giga/L

  4. Incidence of hearing and balance/vestibular disorders [ Time Frame: Up to 10 weeks ]
    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".

  5. Additional renal endpoints: renal failure, dialysis and renal replacement therapy [ Time Frame: Until 10 weeks ]
  6. Any untoward adverse events/reactions [ Time Frame: Up to 10 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003818


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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China
investigational site CHINA Recruiting
China, China
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04003818    
Other Study ID Numbers: LPS16229
U1111-1230-0601 ( Other Identifier: UTN )
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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://www.clinicalstudydatarequest.com/

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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
Additional relevant MeSH terms:
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Infection
Clostridium Infections
Enterocolitis, Pseudomembranous
Colitis
Diarrhea
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Signs and Symptoms, Digestive
Gram-Positive Bacterial Infections
Bacterial Infections
Enterocolitis
Teicoplanin
Anti-Bacterial Agents
Anti-Infective Agents