| Primary | Percentage of Participants With Clinical Response in Clinically Evaluable (CE) Population at Test-of-Cure (TOC) Visit | Clinical response: Cure=All initial signs/symptoms of pneumonia (SSx) improved; chest x-ray (CXR) improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason. | CE population included those participants who met specified evaluability criteria for efficacy. | Posted | | Number | | percentage of participants | | Up to Day 24 to 35 (10 to 21 days after last day of therapy [LDOT]) | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline 75 mg | Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA). | | OG001 | Tigecycline 100 mg | Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA. | | OG002 | Imipenem/Cilastatin 1 Gram | Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA. |
| | | Title | Denominators | Categories |
|---|
| Cure | | | Title | Measurements |
|---|
| - OG00069.6
- OG00185.0
- OG00275.0
|
| | Failure | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Cure: Confidence interval (CI) was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70 percent (%) CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha. | | | | | Risk Difference (RD) | -5.4 | | | 2-Sided | 70 | -21.6 | 10.9 | | | | No | Superiority or Other | | | |
|
| Secondary | Percentage of Participants With Clinical Response in Clinical Modified Intent-to-treat (c-mITT) Population at Test-of-Cure (TOC) Visit | Clinical response: Cure=All initial SSx improved; CXR improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason. | c-mITT population included all participants who were randomly assigned to receive intravenous study medication and had clinical evidence of hospital-acquired pneumonia (HAP). | Posted | | Number | | percentage of participants | | Up to Day 24 to 35 (10 to 21 days after LDOT) | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline 75 mg | Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA). | | OG001 | Tigecycline 100 mg |
|
| Secondary | Percentage of Participants With Clinical Response in Ventilator Associated Pneumonia (VAP) and Non-VAP Participants at Test-of-Cure (TOC) Visit | Clinical response: Cure=All initial SSx improved; CXR improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason. | CE population included those participants who met specified evaluability criteria for efficacy. 'n' is signifying those participants who were evaluable for this measure and included in VAP (suffering from VAP) and non-VAP group (not suffering from VAP) for each group respectively. | Posted | | Number | | percentage of participants | | Up to Day 24 to 35 (10 to 21 days after LDOT) | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline 75 mg | Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA). | | OG001 |
|
| Secondary | Percentage of Participants With Microbiological Response at the Pathogen Level Population at Test-of-Cure (TOC) Visit | Eradication=baseline isolate not present in repeat culture from the original infection site; Presumed Eradication=clinical response of cure precluded the availability of a specimen for culture; Persistence=baseline isolate present in repeat culture from the original infection site; Presumed Persistence=culture data not available for participants with a clinical response of failure; Indeterminate=unable to determine outcome for non-study drug/infection reasons; no baseline isolate; death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason. | Microbiologically Evaluable (ME) population:participants who met evaluability criteria for efficacy, had culture taken from infected site before dose 1 of study drug, had at least (>=)1 pathogen, >=1 pathogen was susceptible to tigecycline, imipenem/cilastatin regimen; 'n' = those participants who had specified pathogen for each group respectively. | Posted | | Number | | percentage of participants | | Up to Day 24 to 35 (10 to 21 days after LDOT) | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline 75 mg | Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA). |
|
| Secondary | Percentage of Participants With Microbiological Response at the Participant Level Population at Test-of-Cure (TOC) Visit | Microbiological response assessed at participant level. Eradication = baseline isolate not present in repeat culture from the original infection site; Presumed Eradication = clinical response of cure precluded the availability of a specimen for culture; Persistence = baseline isolate present in repeat culture from the original infection site; Presumed Persistence = culture data not available for participants with a clinical response of failure; Superinfection = culture from the primary infection site had new pathogen not identified as a baseline isolate and clinical response was failure. | ME population included participants who met specified evaluability criteria for efficacy, had culture taken from the infected site before first dose of study medication and had at least 1 pathogen, and at least 1 baseline pathogen was susceptible to tigecycline and imipenem/cilastatin regimens. | Posted | | Number | | percentage of participants | | Up to Day 24 to 35 (10 to 21 days after LDOT) | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline 75 mg | Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA). | |
|
| Other Pre-specified | Number of Participants Who Experienced Nausea or Vomiting | | Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline up to Day 29 to Day 35 (15 to 21 days after LDOT) | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline 75 mg | Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA). | | OG001 | Tigecycline 100 mg | Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA. | | OG002 | Imipenem/Cilastatin 1 Gram | |
|
| Other Pre-specified | Number of Participants With Abnormal Laboratory Examinations | Participants were evaluated for following laboratory parameters: albumin, alkaline phosphatase, amylase, urea (blood urea nitrogen [BUN]), total bilirubin, calcium, magnesium, carbon dioxide, international normalized ratio (INR), chloride, creatinine, glucose, lipase, potassium, phosphorus, aspartate aminotransferase (AST), alanine aminotransferase (ALT), sodium, total protein, hemoglobin, hematocrit, white blood cells, eosinophils, neutrophils, lymphocytes, platelets, prothrombin time, prothrombin activity and partial thromboplastin time. | mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Number | | participants | | Baseline up to Day 24 to Day 35 (10 to 21 days after LDOT) | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline 75 mg | Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA). | | OG001 | Tigecycline 100 mg | |
|
| Other Pre-specified | Number of Participants With Abnormal Electrocardiogram (ECG) | Potentially clinically significant ECG data: Non-first values greater than 240 millisecond (msec) with increase of greater than or equal to 10 percent (%) from baseline for PR interval; Non-first values greater than or equal to 120 msec for QRS interval; Non-first values greater than 460 msec with increase of greater than or equal to 5% from baseline for corrected QT (QTc) interval; Non-first values greater than 460 msec with increase of greater than or equal to 5% from baseline for QTc using Framingham formula (QTc F). | mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Number | | participants | | Baseline up to Day 14 or LDOT | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline 75 mg | Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA). | | OG001 | Tigecycline 100 mg | Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA. |
|
| Other Pre-specified | Maximum Observed Serum Concentration (Cmax) of Tigecycline | | CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | | Day 3, 4 or 5 | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline 75 mg | Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA). | | OG001 | Tigecycline 100 mg | Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA. |
| |
| Other Pre-specified | Time to Reach Maximum Observed Serum Concentration (Tmax) of Tigecycline | | CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Median | Full Range | hrs | | Day 3, 4 or 5 | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline 75 mg | Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA). | | OG001 | Tigecycline 100 mg | Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA. |
| |
| Other Pre-specified | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Tigecycline | AUC (0-12) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-12). Area under the serum concentration-time curve was derived from the population pharmacokinetic (PK) analysis by using each participant's dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL. | CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | ng*hr/mL | | Day 3, 4 or 5 | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline 75 mg | Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA). | | OG001 | Tigecycline 100 mg | Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA. |
|
| Other Pre-specified | Clearance (CL) of Tigecycline | Drug clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the blood. It is defined as the volume of serum from which drug can be completely removed per unit of time. | CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | 95% Confidence Interval | Liter/hr | | Day 3, 4 or 5 | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline | Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA. |
| |
| Other Pre-specified | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Tigecycline | AUC (0-24) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). Area under the serum concentration-time curve was derived from the population pharmacokinetic (PK) analysis by using each participant's dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL. Model-predicted AUC (0-24) was calculated by multiplying AUC (0-12) by 2. | CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | mg*hr/mL | | Day 3, 4 or 5 | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline 75 mg | Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA). | | OG001 | Tigecycline 100 mg | Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA. |
|
| Other Pre-specified | Correlation of AUC (0-24) of Tigecycline With Nausea and Vomiting | AUC (0-24) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). Area under the serum concentration-time curve was derived from the population PK analysis by using each participant's dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL. Model-predicted AUC (0-24) was calculated by multiplying AUC (0-12) by 2. | CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | mg*hr/mL | | Baseline up to Day 29 to 35 (15 to 21 days after LDOT) | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline | Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA. |
| |
| Other Pre-specified | Correlation of AUC(0-24) to Minimum Inhibitory Concentration (MIC) Ratio (AUC [0-24]/MIC) of Tigecycline With Clinical Outcome | Clinical response:Cure =Initial SSx improved;CXR improved/stable;no other antibiotic for pneumonia;no worsening/new SSx. Failure=Persistence/worsening SSx;no clinical improvement/initial improvement with worsening; other antibiotic;CXR progression;death >study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reason;death in 2 days after dose 1 for any reason or >2 days but before TOC visit for non-pneumonia reason. MIC=lowest drug concentration with no visible growth of microorganism. AUC(0-24)/MIC:reported for cure and failure/indeterminate. | CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | ratio | | Up to Day 24 to 35 (10 to 21 days after LDOT) | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline | Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA. |
| |
| Other Pre-specified | Correlation of AUC(0-24) to Minimum Inhibitory Concentration (MIC) Ratio (AUC [0-24]/MIC) of Tigecycline With Microbiological Outcome | Microbiological response:Eradication=baseline isolate not present in repeat culture from original infection site;Presumed Eradication=clinical response of cure precluded availability of specimen for culture;Persistence=baseline isolate present in repeat culture from original infection site;Presumed Persistence=culture data not available for participants with clinical response of failure;Superinfection=culture from primary infection site had new pathogen not identified as baseline isolate, clinical response was failure. MIC=lowest drug concentration with no visible growth of microorganism. | Data was not analyzed because correlation analysis could not be performed due to insufficient number of participants for whom data for both microbiological outcomes and tigecycline concentration was available. | Posted | | Mean | Standard Deviation | ratio | | Up to Day 24 to 35 (10 to 21 days after LDOT) | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline | Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA. |
| |
| Other Pre-specified | Maximum Observed Plasma Concentration of Procalcitonin (Cmaxpd) and Predicted Procalcitonin Plasma Concentration at 24 Hours (Cpd,24) and 48 Hours (Cpd,48) | | mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | ng/mL | | Baseline up to Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline or Imipenem/Cilastatin | Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs or imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Ceftazidime 2 gram or matching placebo intravenously approximately every 8 hrs, an aminoglycoside, either tobramycin 7 mg/kg daily or amikacin 20 mg/kg daily, and vancomycin 15 mg/kg or matching placebo intravenously at the start of therapy unless it was known at baseline that the participant did not have P. aeruginosa or MRSA. |
| |
| Other Pre-specified | Time to Reach Half of the Maximum Observed Plasma Concentration and Time to Normalization of Concentrations (Tnorm) of Procalcitonin | | Data was not analyzed because there was no apparent change in procalcitonin concentration over time. | Posted | | Median | Full Range | hr | | Baseline up to Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline or Imipenem/Cilastatin | Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs or imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Ceftazidime 2 gram or matching placebo intravenously approximately every 8 hrs, an aminoglycoside, either tobramycin 7 mg/kg daily or amikacin 20 mg/kg daily, and vancomycin 15 mg/kg or matching placebo intravenously every 12 hrs at the start of therapy unless it was known at baseline that the participant did not have P. aeruginosa or MRSA. |
| |
| Other Pre-specified | Duration of Intravenous Antibiotic Treatment, Hospital and Intensive Care Unit (ICU) Stay | | mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for intravenous antibiotic treatment, hospital or ICU stay for each reporting group respectively. | Posted | | Median | Full Range | days | | Baseline up to Day 44 (30 days after LDOT) | | | | ID | Title | Description |
|---|
| OG000 | Tigecycline 75 mg | Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA). | | OG001 | Tigecycline 100 mg | Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA. | | OG002 |
|