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The study investigated the pharmacokinetics, safety, and tolerability of cadazolid in subjects with severe Clostridium difficile diarrhea (CDAD) and whether this influenced the quantity of cadazolid absorbed into the systemic circulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cadazolid | Experimental | Single oral dose of 3000 mg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadazolid | Drug | Cadazolid was provided as dry powder for oral suspension (Amber glass bottles of 60 mL). The powder was reconstituted with tap water by a pharmacist immediately prior to dispensing to subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of cadazolid | 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. | 144 hours |
| Time to reach maximum plasma concentration (tmax) of cadazolid | 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. | 144 hours |
| Area under the plasma concentration-time curve (AUC(0-144h)) of cadazolid | 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. | 144 hours |
| Unchanged cadazolid in urine up to Day 7 | 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. | 144 hours |
| Unchanged cadazolid in faeces up to Day 7 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline up to Day 7 in systolic blood pressure (SBP) | Blood pressure (systolic and diastolic) and pulse rate were measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm = writing arm). Measurements were recorded in the supine position after the subject had rested for a 5-minute period. | 144 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Mackie, MSc | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital for Infective Disease | Zagreb | 1000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26419191 | Derived | Gehin M, Desnica B, Dingemanse J. Minimal systemic and high faecal exposure to cadazolid in patients with severe Clostridium difficile infection. Int J Antimicrob Agents. 2015 Nov;46(5):576-81. doi: 10.1016/j.ijantimicag.2015.07.015. Epub 2015 Sep 3. |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000591679 | cadazolid |
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| 144 hours |
| Change from baseline up to Day 7 in diastolic blood pressure (DBP) | Blood pressure (systolic and diastolic) and pulse rate were measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm = writing arm). Measurements were recorded in the supine position after the subject had rested for a 5-minute period. | 144 hours |
| Change from baseline up to Day 7 in pulse rate | Blood pressure (systolic and diastolic) and pulse rate were measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm = writing arm). Measurements were recorded in the supine position after the subject had rested for a 5-minute period. | 144 hours |
| Change from baseline to Day 7 in body weight | Body weight was measured using the same weighing scales. | 144 hours |
| Change from baseline up to Day 7 in heart rate | Heart rate was determined from standard 12-lead electrocardiographs (ECGs) recorded in the supine position, after a 5-minute period of resting. | 144 hours |
| Change from baseline up to Day 7 in PQ interval (time interval from the beginning of the P wave to the beginning of the QRS complex) | PQ interval was determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting. | 144 hours |
| Change from baseline up to Day 7 in QRS duration (time interval from the beginning of the Q wave to the end of the S wave) | QRS duration was determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting. | 144 hours |
| Change from baseline up to Day 7 in QT (time interval from beginning of the Q wave until end of the T wave) | QT interval was determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting. | 144 hours |
| Change from baseline up to Day 7 in QT interval according to Bazett's correction (QTcB) | QTcB interval was determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting. The QTcB interval is the QT interval (interval from beginning of the Q wave until end of the T wave) corrected for heart rate with Bazett's formula (QTcB = QT/RR^0.5 where RR is 60/heart rate) | 144 hours |
| Change from baseline up to Day 7 in QT interval according to Fridericia's correction (QTcF) | QTcF interval was determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting. The QTcF interval is the QT interval (interval from beginning of the Q wave until end of the T wave) corrected for heart rate with Fridericia's formula (QTcB = QT/RR^0.33 where RR is 60/heart rate) | 144 hours |
| Frequency of treatment-emergent ECG abnormalities from up to Day 7 | Treatment-emergent abnormalities were determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting. An ECG abnormality was considered treatment-emergent if it was not present during the screening period and/or at time of pre-dose assessment. | 144 hours |