Community Acquired PneumoniaNCT02775968
Population Pharmacokinetics of Cephalosporins and Macrolides in Chinese Children With Community Acquired Pneumonia
An observational study of Community Acquired Pneumonia, run by Beijing Children's Hospital at 1 site in China.
Trial summary
This study is based on the hypothesis that the pharmacokinetics of antibiotics in children is different from adults. Cephalosporins and macrolide antibiotics are the common drugs for children with community acquired pneumonia, the investigators aim to study the population pharmacokinetics of cephalosporins and… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- Cephalosporins and Macrolide Antibiotics
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2017to Oct 2022
- Phase
- Observational
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children (1-18 years of age) receiving drugs per standard of care as prescribed by treating caregiver.
Who may be able to join
- Children 1-18 years old of both sexes, with a diagnosis of community acquired pneumonia and eligible for treatment with cephalosporins and macrolide antibiotics, as per current treatment protocols.
- Community acquired pneumonia diagnostic criteria: meet any one of the 1-4 following items plus the fifth item:
- 1. With cough, expectoration, or pre-existing respiratory disease getting worse, and with purulent sputum with or without chest pain;
- 2. Fever;
- 3. With pulmonary consolidation and crackles;
- 4. White blood cells>10×10^9/L or <4×10^9/L;
- 5. X-ray on chest shows flake, patchy infiltrate shadows or interstitial changes, with or without pleural effusion.
- Informed consent signed by the parents, and consent or assent of the patients (according to age and consenting capacity).
Who cannot join
- It is unable to provide complete medical records or the current condition can not accept the diagnosis process.
- It does not agree to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Children's Hospital of Capital Medical University
Beijing
Adong Shen, Master, 13370115087, shenad16@hotmail.com
About this study
Official title: Population Pharmacokinetics of Cephalosporins and Macrolides in Children With Community Acquired Pneumonia
This study is based on the hypothesis that the pharmacokinetics of antibiotics in children is different from adults. Cephalosporins and macrolide antibiotics are the common drugs for children with community acquired pneumonia, the investigators aim to study the population pharmacokinetics of cephalosporins and macrolide antibiotics in children receiving the drug for treatment of community acquired pneumonia, and to correlate it with treatment effectiveness and incidence of adverse effects.
Potential Impact: This novel knowledge will allow better and more rational approaches to the treatment of community acquired pneumonia. It will also set the foundation for further studies that will be able to test improved therapies that may increase treatment response in vulnerable children.
- Conditions
- Community Acquired Pneumonia
- Being tested
- Cephalosporins and Macrolide Antibiotics
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cephalosporins and Macrolide AntibioticsDrug
Also called azithromycin, erythromycin, cefamandole, latamoxef
The intervention drugs are prescribed by treating caregiver.
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum concentration (Cmax)
Measured: up to 4 weeks
Secondary outcomes (4)
time to achieve maximum concentration (Tmax)
Measured: up to 4 weeks
absorption rate constant (ka)
Measured: up to 4 weeks
elimination rate constant (kel)
Measured: up to 4 weeks
half-life (t1/2)
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study start21 Jun 2017
- Primary completionAug 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunling Shen, Beijing Children's Hospital
- Investigators
- A-Dong Shen, Master, Principal investigator, Beijing Children's Hospital of Capital Medical University, ChinaBao-Ping Xu, MD, Principal investigator, Beijing Children's Hospital of Capital Medical University, China; China National Clinical Research Center for Respiratory Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775968
- Sponsor's protocol ID
- BCH_PPK001
- Status last verified
- Jun 2017
- First submitted
- 11 May 2016
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Jacqz-Aigrain E, Leroux S, Zhao W, van den Anker JN, Sharland M. How to use vancomycin optimally in neonates: remaining questions. Expert Rev Clin Pharmacol. 2015;8(5):635-48. doi: 10.1586/17512433.2015.1060124. Epub 2015 Aug 4.
PubMed 26289222Ho PL, Lo PY, Chow KH, Lau EH, Lai EL, Cheng VC, Kao RY. Vancomycin MIC creep in MRSA isolates from 1997 to 2008 in a healthcare region in Hong Kong. J Infect. 2010 Feb;60(2):140-5. doi: 10.1016/j.jinf.2009.11.011. Epub 2009 Dec 2.
PubMed 19961873Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology--drug disposition, action, and therapy in infants and children. N Engl J Med. 2003 Sep 18;349(12):1157-67. doi: 10.1056/NEJMra035092. No abstract available.
PubMed 13679531
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics of Cephalosporins and Macrolides in Children With Community Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT02775968
- Acronym / sponsor ID
- BCH_PPK001
- Conditions
- Community Acquired Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 18 May 2016 (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.
This study is based on the hypothesis that the pharmacokinetics of antibiotics in children is different from adults. Cephalosporins and macrolide antibiotics are the common drugs for children with community acquired pneumonia, the investigators aim to study the population pharmacokinetics of cephalosporins and macrolide antibiotics in children receiving the drug for treatment of community acquired pneumonia, and to correlate it with treatment effectiveness and incidence of adverse effects.
Potential Impact: This novel knowledge will allow better and more rational approaches to the treatment of community acquired pneumonia. It will also set the foundation for further studies that will be able to test improved therapies that may increase treatment response in vulnerable children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children (1-18 years of age) receiving drugs per standard of care as prescribed by treating caregiver.
Key inclusion criteria (8 listed)
- Children 1-18 years old of both sexes, with a diagnosis of community acquired pneumonia and eligible for treatment with cephalosporins and macrolide antibiotics, as per current treatment protocols.
- Community acquired pneumonia diagnostic criteria: meet any one of the 1-4 following items plus the fifth item:
- Informed consent signed by the parents, and consent or assent of the patients (according to age and consenting capacity).
Key exclusion criteria (2 listed)
- It is unable to provide complete medical records or the current condition can not accept the diagnosis process.
- It does not agree to participate in this study.
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 |
|---|---|---|
| Cephalosporins and Macrolide AntibioticsAlso: azithromycin, erythromycin, cefamandole, latamoxefThe intervention drugs are prescribed by treating caregiver. | Drug | – |
Primary outcome
maximum concentration (Cmax)
Time frame: up to 4 weeks
4 secondary outcomes
time to achieve maximum concentration (Tmax)
Time frame: up to 4 weeks
absorption rate constant (ka)
Time frame: up to 4 weeks
elimination rate constant (kel)
Time frame: up to 4 weeks
half-life (t1/2)
Time frame: up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Background: PubMed 26289222Jacqz-Aigrain E, Leroux S, Zhao W, van den Anker JN, Sharland M. How to use vancomycin optimally in neonates: remaining questions. Expert Rev Clin Pharmacol. 2015;8(5):635-48. doi: 10.1586/17512433.2015.1060124. Epub 2015 Aug 4.
- Background: PubMed 19961873Ho PL, Lo PY, Chow KH, Lau EH, Lai EL, Cheng VC, Kao RY. Vancomycin MIC creep in MRSA isolates from 1997 to 2008 in a healthcare region in Hong Kong. J Infect. 2010 Feb;60(2):140-5. doi: 10.1016/j.jinf.2009.11.011. Epub 2009 Dec 2.
- Background: PubMed 13679531Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology--drug disposition, action, and therapy in infants and children. N Engl J Med. 2003 Sep 18;349(12):1157-67. doi: 10.1056/NEJMra035092. No abstract available.
- Individual participant dataSharing planned: Yes
Related trials for Community Acquired Pneumonia
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Active, not recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Community-acquired Pneumonia, CAP
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.
A-Dong Shen, Master principal investigator
Beijing Children's Hospital of Capital Medical University, China
Bao-Ping Xu, MD principal investigator
Beijing Children's Hospital of Capital Medical University, China; China National Clinical Research Center for Respiratory Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community Acquired Pneumonia, run by Beijing Children's Hospital 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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Jun 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact A-Dong Shen, Master (8601059616898, shenad16@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum concentration (Cmax) (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02775968, which also lists 3 linked publications.
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 26 Jun 2017.