The Optimization of Mycoplasm Pneumonia Antibiotic Therapy
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ClinicalTrials.gov Identifier: NCT01259141 |
Recruitment Status
:
Completed
First Posted
: December 14, 2010
Last Update Posted
: July 28, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mycoplasma Pneumonia | Drug: Moxifloxacin Drug: Cephalosporins and azithromycin | Not Applicable |
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 |
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
|
- 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
- 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
- Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms) [ Time Frame: one year ]
- Time to resolution of respiratory symptoms(defined as the period from onset to relief of symptoms) [ Time Frame: one year ]
- Proportion of antibiotics change [ Time Frame: one year ]
- Duration of antibiotics [ Time Frame: one year ]
- Proportion of resolution of fever after antibiotics therapy for 24 hours [ Time Frame: one year ]
- Proportion of resolution of fever after antibiotics therapy for 72 hours [ Time Frame: one year ]
- Antibiotic-related adverse reaction [ Time Frame: one year ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259141
China, Beijing | |
Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute | |
Beijing, Beijing, China, 100020 |
Study Chair: | Bin Cao, Doctor | Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute |
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 Key Record Dates |
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 |