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tigecycline

Phase 3

Abdominal Abscess | Small molecule | Gastrointestinal |Pfizer, Inc.|Last Updated: Feb 8, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

tigecycline · 14 trials · 17 indications

Phase 3 11Phase 1 3
NCT00575094Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese SubjectsCommunity-Acquired Infections
COMPLETED9 Analytics
NCT00366249Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.Bacterial Infections
COMPLETED1,061 Analytics
NCT00136201Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects With Complicated Intra-Abdominal InfectionsAbdominal Abscess
COMPLETED200 Analytics
NCT00081575Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired PneumoniaCommunity-Acquired Infections
COMPLETED434 Analytics
NCT00205816Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.Bacterial Infections
COMPLETED26 Analytics
NCT00079989Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative OrganismsGram-Negative Bacterial Infections
COMPLETED115 Analytics
NCT00079885Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired PneumoniaCommunity Acquired Pneumonia
COMPLETED430 Analytics
NCT00079976Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)Gram-Positive Bacterial Infections
COMPLETED174 Analytics
NCT00080496Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired PneumoniaBacterial Pneumonia
COMPLETED430 Analytics
NCT00081744Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized SubjectsGram-Positive Bacterial Infections
COMPLETED850 Analytics
PHASE3COMPLETED
Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects
Community-Acquired Infections
NCT005750949
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PHASE3COMPLETED
Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.
Bacterial Infections
NCT003662491,061
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PHASE3COMPLETED
Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects With Complicated Intra-Abdominal Infections
Abdominal Abscess
NCT00136201200
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PHASE3COMPLETED
Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia
Community-Acquired Infections
NCT00081575434
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PHASE3COMPLETED
Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.
Bacterial Infections
NCT0020581626
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PHASE3COMPLETED
Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms
Gram-Negative Bacterial Infections
NCT00079989115
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PHASE3COMPLETED
Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia
Community Acquired Pneumonia
NCT00079885430
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PHASE3COMPLETED
Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)
Gram-Positive Bacterial Infections
NCT00079976174
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PHASE3COMPLETED
Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia
Bacterial Pneumonia
NCT00080496430
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PHASE3COMPLETED
Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized Subjects
Gram-Positive Bacterial Infections
NCT00081744850
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Study Endpoints

Primary Endpoints

Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit.
8 weeks

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 nonstudy drug/infection reasons (eg, lost to follow-up); death ≤2 days after first dose for any reason, or \>2 days but before TOC visit for non-pneumonia reason.

Number of Patients With Clinical Response of Cure Vs. Failure.
Test of cure visit (TOC): Assessed at least 12 days post last dose

Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, \>120% doses, non-routine surgical treatment or death related to Diabetic Foot Infections (DFI) \> 48 hrs.

Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.
Test of cure visit (TOC): Assessed at least 12 days post last dose

Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, \>120% doses, non-routine surgical treatment or death related to DFI \> 48 hrs. Indeterminate: Lost to follow-up, death\<48 hours or noninfection related.

Clinical response for all microbiologically evaluable and microbiologically modified intent-to-treat subjects at the test-of-cure visit
Clinical response in the clinically evaluable population and the clinical modified intent-to-treat population at the TOC visit.
Determine whether tigecycline is noninferior to levofloxacin.
response
The co-primary efficacy endpoints are clinical response at the TOC assessment for the clinically evaluable population and the clinical modified intent-to-treat population.
The primary efficacy endpoint was the clinical response in the co-primary populations of the clinically evaluable (CE) and clinical modified intent-to-treat (c-mITT) subjects at the test-of-cure assessment.
Change from baseline in serial QTc measurements in healthy volunteers up to 96 hours after single tigecycline doses
Up to 96 hours
To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction.
5 days
To determine both the bone and corresponding serum concentration of tigecycline at selected time points following adminstration.
1 day

Secondary Endpoints

Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.
Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose
Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.
Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose
Number of Patients With Microbiologic Response of Eradication.
Test of cure visit (TOC): Assessed at least 12 days post last dose
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AACTIVE_COMPARATOR -
BACTIVE_COMPARATOR -
1EXPERIMENTALarmDesc1
high dose tigecyclineEXPERIMENTAL -
regular dose tigecyclineEXPERIMENTAL -
moxifloxacinACTIVE_COMPARATOR -
placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
tigecyclineDRUGDosage form: Tigecycline 50 mg for injection (Lyophilized powder in 5 mL vial) Dosage frequency: Tigecycline 100 mg loading followed by 50 mg every 12 hrs (bid) Duration of therapy: 7 to 14 days
ErtapenemDRUGErtapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
LevofloxacinDRUG -
ImipenemDRUG -
CilastatinDRUG -
vancomycin with aztreonamDRUG -
moxifloxacinDRUGoral tablet, 400 mg, single dose
100 mL 0.9% Sodium Chloride intravenousDRUGintravenous fluid, 100 mL, single dose
placeboDRUG0.9% Sodium Chloride intravenous 100mL, single dose
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Hospitalized Japanese descent subjects known or suspected to have CAP with a severity that requires IV antibiotic treatment. * Chest radiograph within 48 hours before the first dose of IV test article showing the presence of a new infiltrate. * The presence of fever or hypothe...

Countries:JapanUnited StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaChileChinaColombiaCroatiaDenmarkEstoniaFinlandFranceGermanyGreeceHungaryIndiaItalyLatviaLithuaniaMexicoPanamaPeruPolandPortugalRomaniaRussiaSlovakiaSouth AfricaSouth KoreaSpainSwedenSwitzerlandTaiwanTurkey (Türkiye)UkraineUnited KingdomPuerto Rico
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