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Antibiotic

Phase 3

Pneumonia, Pneumococcal | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Apr 26, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment230

FDA Designations

No designations recorded

Clinical trial landscape

Antibiotic · 1 trial · 3 indications

Phase 3 1
NCT00035269New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)Pneumonia, Pneumococcal
COMPLETED230 Analytics
PHASE3COMPLETED
New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)
Pneumonia, PneumococcalUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the microbiologic efficacy of linezolid in the treatment of patients with pneumonia caused by penicillin-resistant Streptococcus pneumoniae (PRSP).
Additionally, microbiologic efficacy will be assessed in all pneumonia patients infected with S pneumoniae SP) and in those infected with penicillin-sensitive (PSSP) and penicillin-intermediate (PISP) S pneumoniae.

Secondary Endpoints

To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
AntibioticDRUG -
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Eligibility Criteria

Age Range13 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites46

Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary. Inclusion Criteria: * Patients must have the signs and symptoms of pneumonia, with a chest xray showing a pneumonia. * The patient must have S. pneumoniae...

Countries:United StatesSlovakiaSpainTaiwan
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Frequently asked questions about Antibiotic

What is Antibiotic used for?

Antibiotic is an investigational small molecule being developed for pneumococcal pneumonia, specifically community-acquired pneumonia caused by Streptococcus pneumoniae. It is intended for patients with this specific bacterial infection, including those with gram-positive bacterial infections. The drug is currently in Phase 3 clinical development and is not yet approved.

Who makes Antibiotic?

Antibiotic is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the drug's safety and efficacy in treating pneumococcal pneumonia.

What phase is Antibiotic in?

Antibiotic is in Phase 3 clinical development. It has completed one Phase 3 trial, which was an uncontrolled study with 230 participants. The drug remains investigational and has not been approved by regulatory authorities for commercial use.

What clinical trials is Antibiotic in?

Antibiotic has one completed clinical trial registered under NCT00035269, titled 'New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)'. This Phase 3 study enrolled 230 participants across the United States, Slovakia, Spain, and Taiwan, and included patients aged 13 years and older.

Is Antibiotic FDA approved?

Antibiotic is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. The completed trial, NCT00035269, was an uncontrolled study, and the drug has not yet received regulatory approval for treating pneumococcal pneumonia.