Mycoplasma PneumoniaNCT01259141
The Optimization of Mycoplasm Pneumonia Antibiotic Therapy
A study testing Moxifloxacin and Cephalosporins and azithromycin in people with Mycoplasma Pneumonia, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mycoplasma Pneumonia
- What is being tested?
- Moxifloxacin and Cephalosporins and azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
Beijing, Beijing Municipality, 100020
About this study
Official title: The Optimization of Mycoplasm Pneumonia Antibiotic Therapy: Multi-centre, Prospective, Randomized Controlled Study
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.
Read the 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.
- Conditions
- Mycoplasma Pneumonia
- Being tested
- Moxifloxacin, Cephalosporins and azithromycin
- Keywords
- macrolide- resistant Mycoplasma pneumoniae,, Mycoplasm pneumonia antibiotic therapy
- Medical subject headings
- Pneumonia, Mycoplasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxifloxacinDrug
0.4 Qd for 7days
Cephalosporins and azithromycinDrug
cefuroxime 1.5 bid for 7 days plus azithromycin 0.5 qd for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin | Experimental | Not described Receives: Drug: Moxifloxacin |
| Cephalosporins and azithromycin | Experimental | Not described Receives: Drug: Cephalosporins and azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month
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
Measured: one month
Secondary outcomes (7)
Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)
Measured: one year
Time to resolution of respiratory symptoms(defined as the period from onset to relief of symptoms)
Measured: one year
Proportion of antibiotics change
Measured: one year
Duration of antibiotics
Measured: one year
Proportion of resolution of fever after antibiotics therapy for 24 hours
Measured: one year
Proportion of resolution of fever after antibiotics therapy for 72 hours
Measured: one year
Antibiotic-related adverse reaction
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycoplasma PneumoniaStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Cao, Capital Medical University
- Investigators
- Bin Cao, Doctor, Study chair, Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259141
- Sponsor's protocol ID
- MP201011
- Status last verified
- Jul 2015
- First submitted
- 13 Dec 2010
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimization of Mycoplasm Pneumonia Antibiotic Therapy: Multi-centre, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01259141
- Acronym / sponsor ID
- MP201011
- Conditions
- Mycoplasma Pneumonia
- Keywords
- macrolide- resistant Mycoplasma pneumoniae,, Mycoplasm pneumonia antibiotic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin | Experimental | Drug: Moxifloxacin |
| Cephalosporins and azithromycin | Experimental | Drug: Cephalosporins and azithromycin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxifloxacin0.4 Qd for 7days | Drug | Moxifloxacin |
| Cephalosporins and azithromycincefuroxime 1.5 bid for 7 days plus azithromycin 0.5 qd for 7 days | Drug | Cephalosporins and azithromycin |
Primary outcome
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Cao, Doctor study chair
Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moxifloxacin and Cephalosporins and azithromycin in people with Mycoplasma Pneumonia, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to resolution of fever (defined as the period from start of study-drug to relief of fever) (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.