Back to results

The Optimization of Mycoplasm Pneumonia Antibiotic Therapy

Primary Purpose

Mycoplasma Pneumonia

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Moxifloxacin

Cephalosporins and azithromycin

About this trial

This is an interventional treatment trial for Mycoplasma Pneumonia focused on measuring macrolide- resistant Mycoplasma pneumoniae,, Mycoplasm pneumonia antibiotic therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Moxifloxacin

Cephalosporins and azithromycin

Arm Description

Outcomes

Primary Outcome Measures

Time to resolution of fever (defined as the period from start of study-drug to relief of fever)

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)

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 to resolution of respiratory symptoms(defined as the period from onset to relief of symptoms)

Proportion of antibiotics change

Duration of antibiotics

Proportion of resolution of fever after antibiotics therapy for 24 hours

Proportion of resolution of fever after antibiotics therapy for 72 hours

Antibiotic-related adverse reaction

Full Information

NCT ID

NCT01259141

First Posted

December 13, 2010

Last Updated

July 25, 2015

Sponsor

Capital Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01259141

Brief Title

The Optimization of Mycoplasm Pneumonia Antibiotic Therapy

Official Title

The Optimization of Mycoplasm Pneumonia Antibiotic Therapy: Multi-centre, Prospective, Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Capital Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mycoplasma Pneumonia

Keywords

macrolide- resistant Mycoplasma pneumoniae,, Mycoplasm pneumonia antibiotic therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

208 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moxifloxacin

Arm Type

Experimental

Arm Title

Cephalosporins and azithromycin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Moxifloxacin

Intervention Description

0.4 Qd for 7days

Intervention Type

Drug

Intervention Name(s)

Cephalosporins and azithromycin

Intervention Description

cefuroxime 1.5 bid for 7 days plus azithromycin 0.5 qd for 7 days

Primary Outcome Measure Information:

Title

Time to resolution of fever (defined as the period from start of study-drug to relief of fever)

Description

usually duration of fever is about one to two weeks

Time Frame

one month

Title

Time to resolution of fever (defined as the period from onset to relief of fever)

Description

usually duration of fever is about one to two weeks

Time Frame

one month

Secondary Outcome Measure Information:

Title

Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)

Time Frame

one year

Title

Time to resolution of respiratory symptoms(defined as the period from onset to relief of symptoms)

Time Frame

one year

Title

Proportion of antibiotics change

Time Frame

one year

Title

Duration of antibiotics

Time Frame

one year

Title

Proportion of resolution of fever after antibiotics therapy for 24 hours

Time Frame

one year

Title

Proportion of resolution of fever after antibiotics therapy for 72 hours

Time Frame

one year

Title

Antibiotic-related adverse reaction

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bin Cao, Doctor

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100020

Country

China

12. IPD Sharing Statement

Learn more about this trial

The Optimization of Mycoplasm Pneumonia Antibiotic Therapy

We'll reach out to this number within 24 hrs