Efficacy and Safety of Teicoplanin in CDAD

• ClinicalTrials.gov Identifier: NCT04003818
• Recruitment Status: Terminated
• First Posted: July 1, 2019
• Last Update Posted: April 25, 2022
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

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

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

Detailed Description:

Approximate 10 weeks

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Primary Completion Date: January 21, 2021
• Actual Study Completion Date: March 10, 2021

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

China

investigational site CHINA

China, China

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

More Information

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT04003818
• Other Study ID Numbers: LPS16229; U1111-1230-0601 ( Other Identifier: UTN )
• First Posted: July 1, 2019
• Last Update Posted: April 25, 2022
• Last Verified: April 2022

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://vivli.org

• 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:

Infections; Clostridium Infections; Colitis; Diarrhea; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Teicoplanin; Anti-Bacterial Agents; Anti-Infective Agents