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Cilastatin

Phase 3

Bacterial Pneumonia | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Aug 4, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment430

FDA Designations

No designations recorded

Clinical trial landscape

Cilastatin · 1 trial · 1 indication

Phase 3 1
NCT00080496Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired PneumoniaBacterial Pneumonia
COMPLETED430 Analytics
PHASE3COMPLETED
Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia
Bacterial PneumoniaUnlock trial analytics

Study Endpoints

Primary Endpoints

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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
TigecyclineDRUG -
ImipenemDRUG -
CilastatinDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: * Male or female subjects over 18 years of age. Bulgaria Only: Male or female subjects over 18 years of age and under 70 years of age. * Subjects known or suspected to have acute hospital-acquired pneumonia. Exclusion Criteria: * Presence of any of the following pulmonary cond...

Countries:United States
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Frequently asked questions about Cilastatin

What is Cilastatin used for in Bacterial Pneumonia?

Cilastatin is a small molecule being studied for the treatment of Bacterial Pneumonia. It is part of a combination therapy with imipenem, evaluated in a Phase 3 clinical trial for hospital-acquired pneumonia. The drug is investigational and not yet approved for this indication.

What does Cilastatin target?

Cilastatin does not have a specific molecular target; it is a renal dehydropeptidase inhibitor that prevents the metabolism of imipenem in the kidneys, thereby increasing its concentration and effectiveness. It is used in combination with imipenem to treat bacterial infections.

Who makes Cilastatin?

Cilastatin is developed by Pfizer, Inc., a company publicly traded under the ticker symbol PFE. Pfizer is conducting clinical research on this drug for the treatment of Bacterial Pneumonia.

What phase is Cilastatin in?

Cilastatin is in Phase 3 clinical development. A Phase 3 trial, NCT00080496, has been completed, evaluating the drug in combination with imipenem for hospital-acquired pneumonia. It remains investigational and has not received FDA approval.

What clinical trials is Cilastatin in?

Cilastatin has one completed Phase 3 clinical trial, NCT00080496, titled 'Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia.' This randomized, double-blind trial enrolled 430 participants in the United States and was not controlled.

Is Cilastatin the same as Imipenem?

No, Cilastatin is not the same as Imipenem. Cilastatin is a separate drug that is combined with imipenem to prevent its breakdown in the kidneys. The combination is used to treat bacterial infections, including hospital-acquired pneumonia.