Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
sulopenem and PF-03709270 · 1 trial · 1 indication
Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At TOC (7 to 14 days after end of treatment \[EOT\]) CR was evaluated as "cure"=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; "failure"=persistence or progression of baseline signs and symptoms of pneumonia (for example: body temperature, white blood cell \[WBC\] count, respiratory rate, auscultatory findings, cough, sputum production), development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; "indeterminate"=extenuating circumstances precluded classification to 1 of the above.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Loading dose of IV sulopenem with switch to oral PF-03709270 |
| 2 | EXPERIMENTAL | IV sulopenem with switch to oral PF-03709270 |
| 3 | ACTIVE_COMPARATOR | IV ceftriaxone with switch to oral amoxicillin/clavulanate potassium comparator |
| Name | Type | Description |
|---|---|---|
| sulopenem and PF-03709270 | DRUG | Sulopenem - 600 mg infused over 1 hour, single loading dose and switch to oral PF-03709270 - 1000 mg twice a day |
| Ceftriaxone and amoxicillin/clavulanate | DRUG | IV ceftriaxone (2g) infused over 30 minutes QD (once daily) for minimum of 2 days Step down oral amoxicillin/clavulanate potassium suspension (400 mg/5 ml) BID (every 12 hours) |
Inclusion Criteria: * Hospitalized male or female patients 18 years of age or older. * Female patients of childbearing potential must not be pregnant. * Must exhibit at least two pre-specified clinical symptoms/signs of pneumonia. * Must require hospitalization for the pneumonia. * Chest Xray must ...
Sulopenem and PF-03709270 is an investigational small molecule being studied for the treatment of bacterial pneumonia, specifically community acquired pneumonia that requires hospitalization. It is administered intravenously and orally. The drug is currently in Phase 2 clinical development and is not approved by regulatory authorities.
Sulopenem and PF-03709270 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is in Phase 2 clinical development for the treatment of bacterial pneumonia.
Sulopenem and PF-03709270 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial for the treatment of bacterial pneumonia has been completed.
Sulopenem and PF-03709270 has one completed Phase 2 clinical trial, registered as NCT00797108. The trial studied intravenous sulopenem and oral PF-03709270 in community acquired pneumonia requiring hospitalization. It enrolled 35 participants across the United States, Australia, Canada, Poland, and South Korea.
Sulopenem and PF-03709270 refers to a combination of two components: sulopenem, an intravenous antibiotic, and PF-03709270, an oral formulation. The drug is being studied for the treatment of bacterial pneumonia. The clinical trial NCT00797108 evaluated both components together.