---
title: The Optimization of Mycoplasm Pneumonia Antibiotic Therapy
nct_id: NCT01259141
overall_status: COMPLETED
phase: NA
sponsor: Capital Medical University
study_type: INTERVENTIONAL
primary_condition: Mycoplasma Pneumonia
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01259141.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01259141"
ct_last_update_post_date: 2015-07-28
last_seen_at: "2026-05-12T07:06:37.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Optimization of Mycoplasm Pneumonia Antibiotic Therapy

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

**NCT ID:** [NCT01259141](https://clinicaltrials.gov/study/NCT01259141)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 208
- **Lead Sponsor:** Capital Medical University
- **Conditions:** Mycoplasma Pneumonia
- **Start Date:** 2010-10
- **Completion Date:** 2014-12
- **CT.gov Last Update:** 2015-07-28

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Moxifloxacin** (EXPERIMENTAL)
- **Cephalosporins and azithromycin** (EXPERIMENTAL)

## Interventions

- **Moxifloxacin** (DRUG) — 0.4 Qd for 7days
- **Cephalosporins and azithromycin** (DRUG) — cefuroxime 1.5 bid for 7 days plus azithromycin 0.5 qd for 7 days

## Primary Outcomes

- **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

## 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)_

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.capital medical university affiliated beijing chaoyang hospital, beijing respiratory medicine insititute|beijing|beijing municipality|china` — added _(2026-05-12)_

---

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