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cefuroxime plus erythromycin

Phase 3

Pneumonia | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Apr 1, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment139

FDA Designations

No designations recorded

Clinical trial landscape

cefuroxime plus erythromycin · 1 trial · 1 indication

Phase 3 1
NCT00648726An Open, Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Intravenous Followed by Oral Azithromycin Versus Cefuroxime Alone or With Oral Erythromycin for the Treatment of Chinese Patients Who Were Hospitalized for PneumoniaPneumonia
COMPLETED139 Analytics
PHASE3COMPLETED
An Open, Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Intravenous Followed by Oral Azithromycin Versus Cefuroxime Alone or With Oral Erythromycin for the Treatment of Chinese Patients Who Were Hospitalized for Pneumonia
PneumoniaUnlock trial analytics

Study Endpoints

Primary Endpoints

clinical efficacy (cure or marked improvement)
Visit 3 (Day 9 +-1 of treatment)

Secondary Endpoints

bacteriological efficacy (eradication)
Visit 3
clinical efficacy
Visit 4 (8 +/-1 days after treatment)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATOR -
Arm 2ACTIVE_COMPARATOR -
Arm 3ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
cefuroxime plus erythromycinDRUGintravenous cefuroxime 1.5 g twice daily for 4 +/-1 days, followed by oral cefuroxime 0.5 g twice daily for a total duration of 9 +/-1 days plus erythromycin ethylsuccinate 0.5 g twice daily, which was given for a total duration of 14 days for subjects with suspected pneumonia due to atypical pathogens
azithromycin (Zithromax)DRUGintravenous azithromycin 500 mg once daily for 4 +/-1 days, followed by oral azithromycin 500 mg once daily for a total duration of 9 +/-1 days
cefuroximeDRUGintravenous cefuroxime 1.5 g twice daily for 4 +/-1 days, followed by oral cefuroxime 0.5 g twice daily for a total duration of 9 +/-1 days
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: Inclusion Criteria: * Patients hospitalized with a diagnosis of community acquired pneumonia (CAP) as defined by the presence of new infiltrate(s) including manifestation of consolidation, patchy, diffuse or interstitial inflammation on chest X-ray with or without pleural effus...

Countries:China
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Frequently asked questions about cefuroxime plus erythromycin

What is cefuroxime plus erythromycin used for?

Cefuroxime plus erythromycin is an investigational combination of two small-molecule antibiotics being studied for the treatment of pneumonia in hospitalized patients. It is being developed by Pfizer, Inc. (NYSE: PFE) and has completed a Phase 3 clinical trial in China.

Who makes cefuroxime plus erythromycin?

Cefuroxime plus erythromycin is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE on the New York Stock Exchange. The combination is intended for the treatment of pneumonia and has been evaluated in a Phase 3 clinical trial.

What phase is cefuroxime plus erythromycin in?

Cefuroxime plus erythromycin is in Phase 3 clinical development. It is an investigational combination therapy and has not been approved by regulatory authorities. A Phase 3 trial for the treatment of pneumonia has been completed, but the drug remains under clinical investigation.

What clinical trials is cefuroxime plus erythromycin in?

Cefuroxime plus erythromycin has one completed Phase 3 clinical trial, registered as NCT00648726. This open, prospective, randomized, multicenter study evaluated the efficacy and safety of intravenous followed by oral azithromycin versus cefuroxime alone or with oral erythromycin in 139 Chinese patients hospitalized for pneumonia.

Is cefuroxime plus erythromycin the same as cefuroxime alone?

Cefuroxime plus erythromycin is a combination of cefuroxime and erythromycin, two antibiotics. It is distinct from cefuroxime alone, which was used as a comparator in the Phase 3 trial NCT00648726. The combination was studied to determine if adding erythromycin improves outcomes in hospitalized pneumonia patients.