Efficacy and Safety of Teicoplanin in CDAD

NCT04003818 | Terminated Phase 4

• 2 other identifiers: LPS16229U1111-1230-0601
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Clostridium Difficile Infection-associated Diarrhea and Colitis

Outcome Measures

Primary Outcomes (3)

• 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)

  2 days after 7-14 days treatment

• Recurrence rate

  Recurrence is defined as reappearance of diarrhea during the 8-week follow-up period.

  Up to 10 weeks

• 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.

  Up to 10 weeks

Secondary Outcomes (6)

• Incidence of nephrotoxicity

  Until 10 weeks

• Incidence of hepatotoxicit

  Up to 10 weeks

• Incidence of thrombocytopenia

  Up to 10 weeks

• Incidence of hearing and balance/vestibular disorders

  Up to 10 weeks

• Additional renal endpoints: renal failure, dialysis and renal replacement therapy

  Until 10 weeks

Study Arms (1)

Teicoplanin

EXPERIMENTAL

teicoplanin, administered orally 100-200 mg, twice a day

Drug: TEICOPLANIN

Interventions

TEICOPLANIN DRUG

Pharmaceutical form:solution for oral administration Route of administration: oral

Teicoplanin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

investigational site CHINA

China, China

Location

Related Links

• LPS16229 Plain Language Results Summary

MeSH Terms

Conditions

Colitis

Interventions

Teicoplanin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Lipoglycopeptides; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: July 1, 2019
• Study Start: May 15, 2020
• Primary Completion: January 21, 2021
• Study Completion: March 10, 2021
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)