The Optimization of Mycoplasm Pneumonia Antibiotic Therapy

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Mycoplasma Pneumonia	Drug: Moxifloxacin; Drug: Cephalosporins and azithromycin	Not Applicable

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	208 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	The Optimization of Mycoplasm Pneumonia Antibiotic Therapy: Multi-centre, Prospective, Randomized Controlled Study
Study Start Date :	October 2010
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	December 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Time to resolution of fever (defined as the period from start of study-drug to relief of fever) [ Time Frame: one month ]
   usually duration of fever is about one to two weeks
2. Time to resolution of fever (defined as the period from onset to relief of fever) [ Time Frame: one month ]
   usually duration of fever is about one to two weeks

Secondary Outcome Measures :

1. Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms) [ Time Frame: one year ]
2. Time to resolution of respiratory symptoms(defined as the period from onset to relief of symptoms) [ Time Frame: one year ]
3. Proportion of antibiotics change [ Time Frame: one year ]
4. Duration of antibiotics [ Time Frame: one year ]
5. Proportion of resolution of fever after antibiotics therapy for 24 hours [ Time Frame: one year ]
6. Proportion of resolution of fever after antibiotics therapy for 72 hours [ Time Frame: one year ]
7. Antibiotic-related adverse reaction [ Time Frame: one year ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Confirmed community acquired pneumonia
2. 60ys≥age≥18 ys
3. Respiratory symptom (cough accompanied by little or no sputum)
4. New infiltration showed by chest radiology(x-ray or CT)
5. Lung signs was not obvious
6. White blood cell<10,000/mm3
7. Without underlying diseases or mild

Exclusion Criteria:

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Bin Cao, Professor, Capital Medical University
ClinicalTrials.gov Identifier:	NCT01259141 History of Changes
Other Study ID Numbers:	MP201011
First Posted:	December 14, 2010
Last Update Posted:	July 28, 2015
Last Verified:	July 2015

Keywords provided by Bin Cao, 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