The Optimization of Mycoplasm Pneumonia Antibiotic Therapy - Full Text View

Purpose

Mycoplasma pneumoniae, an important pathogen of community acquired pneumonia,are becoming more and more resistant to macrolide. The study aim is to optimize anti-infection therapy.

Condition	Intervention
Mycoplasma Pneumonia	Drug: Moxifloxacin Drug: Cephalosporins and azithromycin


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Optimization of Mycoplasm Pneumonia Antibiotic Therapy: Multi-centre, Prospective, Randomized Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Pneumonia

Drug Information available for: Azithromycin Moxifloxacin Moxifloxacin hydrochloride

Genetic and Rare Diseases Information Center resources: Mycoplasmal Pneumonia

U.S. FDA Resources

Further study details as provided by Capital Medical University:

Primary Outcome Measures:

Time to resolution of fever (defined as the period from start of study-drug to relief of fever) [ Time Frame: one month ] [ Designated as safety issue: No ]
usually duration of fever is about one to two weeks
Time to resolution of fever (defined as the period from onset to relief of fever) [ Time Frame: one month ] [ Designated as safety issue: No ]
usually duration of fever is about one to two weeks

Secondary Outcome Measures:

Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms) [ Time Frame: one year ] [ Designated as safety issue: No ]
Time to resolution of respiratory symptoms(defined as the period from onset to relief of symptoms) [ Time Frame: one year ] [ Designated as safety issue: No ]
Proportion of antibiotics change [ Time Frame: one year ] [ Designated as safety issue: No ]
Duration of antibiotics [ Time Frame: one year ] [ Designated as safety issue: No ]
Proportion of resolution of fever after antibiotics therapy for 24 hours [ Time Frame: one year ] [ Designated as safety issue: No ]
Proportion of resolution of fever after antibiotics therapy for 72 hours [ Time Frame: one year ] [ Designated as safety issue: No ]
Antibiotic-related adverse reaction [ Time Frame: one year ] [ Designated as safety issue: No ]


Enrollment:	208
Study Start Date:	October 2010
Study Completion Date:	December 2014
Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Moxifloxacin	Drug: Moxifloxacin 0.4 Qd for 7days
Experimental: Cephalosporins and azithromycin	Drug: Cephalosporins and azithromycin cefuroxime 1.5 bid for 7 days plus azithromycin 0.5 qd for 7 days

Detailed Description:

Mycoplasma pneumoniae was one of important atypical pathogens of community acquired pneumonia. As lack of cell wall, β-lactam medicines were invalid, however, macrolides, tetracyclines and quinolones were effective. But from 2001, many countries reported macrolide- resistant Mycoplasma pneumoniae. Typically, erythromycin was first-line antibiotic medicine. With the resistance increasing, Mycoplasm pneumonia treatment will become more and more difficult. Thus, optimization of Mycoplasm pneumonia antibiotic therapy is very important.

Eligibility


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed community acquired pneumonia
60ys≥age≥18 ys
Respiratory symptom (cough accompanied by little or no sputum)
New infiltration showed by chest radiology(x-ray or CT)
Lung signs was not obvious
White blood cell<10,000/mm3
Without underlying diseases or mild

Exclusion Criteria:

Age<18ys or >60ys
Pregnancy or breast-feeding
Over one week after the onset of symptoms
HIV infection
Recent 90-day hospitalized history(length of stay greater than 2 days)
Live in nursing homes or rehabilitation hospitals
Taken macrolides or quinolones medicines before enrollment

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259141

Locations


China, Beijing
Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
Beijing, Beijing, China, 100020

Sponsors and Collaborators

Capital Medical University

Investigators


Study Chair:	Bin Cao, Doctor	Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute

More Information


Responsible Party:	Bin Cao, Professor, Capital Medical University
ClinicalTrials.gov Identifier:	NCT01259141 History of Changes
Other Study ID Numbers:	MP201011
Study First Received:	December 13, 2010
Last Updated:	July 25, 2015
Health Authority:	China: Beijing Municipal Science and Technology Commission

Keywords provided by Capital Medical University:


macrolide- resistant Mycoplasma pneumoniae, Mycoplasm pneumonia antibiotic therapy

Additional relevant MeSH terms:


Pneumonia Pleuropneumonia Mycoplasma Infections Pneumonia, Mycoplasma Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Pleurisy Pleural Diseases Mycoplasmatales Infections Gram-Negative Bacterial Infections Bacterial Infections Pneumonia, Bacterial Anti-Bacterial Agents Moxifloxacin	Cephalosporins Antibiotics, Antitubercular Norgestimate, ethinyl estradiol drug combination Anti-Infective Agents Antitubercular Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents

Pneumonia
Pleuropneumonia
Mycoplasma Infections
Pneumonia, Mycoplasma
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pleurisy
Pleural Diseases
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Anti-Bacterial Agents
Moxifloxacin

Cephalosporins
Antibiotics, Antitubercular
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on September 26, 2016