Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cadazolid · 4 trials · 1 indication
Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement 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 between first dose of study drug and 2 days after EOT. CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.
Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement 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 between first dose of study drug and 2 days after EOT. CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.
Percentages of subjects with clinical cure are calculated, with clinical cure being defined as resolution of diarrhea with no further Clostridium Difficile-associated diarrhea (CDAD) treatment required at test-of-cure (TOC) visit. Resolution of diarrhea was defined as the occurrence of ≤ 2 semi-formed or formed stools during 24 h for at least 2 consecutive 24 h periods.
Blood samples for pharmacokinetic analysis taken immediately prior to dosing with cadazolid, and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after dosing. Cmax was calculated on the basis of the blood sampling time points.
Blood samples for pharmacokinetic analysis taken immediately prior to dosing with cadazolid, and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after dosing. tmax was calculated on the basis of the blood sampling time points.
Blood samples for pharmacokinetic analysis taken immediately prior to dosing with cadazolid, and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after dosing. AUC(0-144) was calculated according to the linear trapezoidal rule using the measured concentration-time values above the limit of quantification.
Urine was collected into standard-weight polyethylene containers over the following time intervals: 0-12 h, 12-24 h, 24-36 h, 36-48 h, 48-72 h, 72-96 h, 96-120 h, and 120-144 h. The concentration of cadazolid was determined using validated liquid chromatography-tandem mass spectrometry assays. The amount of drug excreted in the urine was obtained by multiplying the concentration of drug by the volume of matrix collected.
Faeces were collected in pre-weighed polypropylene boxes. The concentration of cadazolid was determined using validated liquid chromatography-tandem mass spectrometry assays. The amount of drug excreted in the faeces was obtained by multiplying the concentration of drug by the volume of matrix collected.
| Arm | Type | Description |
|---|---|---|
| Cadazolid | EXPERIMENTAL | Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days |
| Vancomycin | ACTIVE_COMPARATOR | Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days |
| Cadazolid 250 mg | EXPERIMENTAL | Subjects received 250 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days |
| Cadazolid 500 mg | EXPERIMENTAL | Subjects received 500 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days |
| Cadazolid 1000 mg | EXPERIMENTAL | Subjects received 1000 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days |
| Vancomycin 125 mg | ACTIVE_COMPARATOR | Subjects received one vancomycin capsule (125 mg) four times daily and reconstituted placebo-matching cadazolid suspension twice daily for 10 days |
| Name | Type | Description |
|---|---|---|
| Cadazolid | DRUG | Cadazolid 250 mg as oral suspension twice daily. |
| Vancomycin | DRUG | Vancomycin 125 mg as oral capsules 4 times daily. |
| Cadazolid-matching placebo | DRUG | Placebo matching cadazolid and administered orally twice daily |
| Vancomycin-matching placebo | DRUG | Placebo capsules matching vancomycin and administered orally 4 times per day |
| Placebo-matching cadazolid | DRUG | Placebo of cadazolid powder for oral suspension |
| Placebo-matching vancomycin | DRUG | Placebo of vancomycin capsules |
Inclusion Criteria: * Signed Informed Consent. * Male or female ≥ 18 years of age. Females of childbearing potential must agree to use an adequate and reliable method of contraception. * Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) ...
Cadazolid is an investigational small molecule being developed for the treatment of Clostridium difficile infection, also known as C. diff. It is designed to address Clostridium difficile-associated diarrhea. The drug is still in clinical development and has not been approved by regulatory authorities.
Cadazolid is an antibiotic that targets Clostridium difficile bacteria. It works by inhibiting bacterial protein synthesis, which prevents the bacteria from growing and multiplying. This mechanism is intended to treat Clostridium difficile infection, a serious gastrointestinal condition.
Cadazolid is being developed by Johnson & Johnson, a multinational pharmaceutical company. The company is listed on the stock exchange under the ticker symbol JNJ. Johnson & Johnson has conducted clinical trials to evaluate the safety and efficacy of Cadazolid in patients with Clostridium difficile infection.
Cadazolid has completed Phase 3 clinical trials for Clostridium difficile infection. The drug has undergone testing in multiple phases, including Phase 1, Phase 2, and Phase 3 studies. However, it remains an investigational drug and has not received FDA approval.
Cadazolid has been studied in four completed clinical trials. These include NCT01222702, a Phase 2 study with 84 participants; NCT01983683 and NCT01987895, both Phase 3 trials with over 600 participants each; and NCT02053181, a Phase 1 pharmacokinetic study with 6 participants. All trials focused on Clostridium difficile infection.
No, Cadazolid is not the same as vancomycin. Cadazolid is an investigational antibiotic being developed by Johnson & Johnson, while vancomycin is an established antibiotic used as a standard treatment for Clostridium difficile infection. In clinical trials, Cadazolid was compared against vancomycin as an active control.