Acute Upper Respiratory Tract InfectionNCT01930955
Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection
A study testing Amoxicillin in people with Acute Upper Respiratory Tract Infection, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Some acute upper respiratory tract infection(AURI) in children is characterized by fever and vomiting,and it is one common reason for visiting a pediatrician. White blood count(WBC) usually increased in this children patients,hence antibiotics are often prescribed properly assumed. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Acute Upper Respiratory Tract Infection
- What is being tested?
- Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2011to 30 Dec 2022
- 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 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Acute upper respiratory tract infection
- Fever
- Vomiting
- Increased white blood cell
Who cannot join
- 0ther symptoms of digestive system
- Headache
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Official title: Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection：a Randomized-control Trial
Some acute upper respiratory tract infection(AURI) in children is characterized by fever and vomiting,and it is one common reason for visiting a pediatrician. White blood count(WBC) usually increased in this children patients,hence antibiotics are often prescribed properly assumed. In the present study, it was hypothesized that it was not necessary to prescribe amoxicillin for the children.
Read the detailed description
After inclusion of eligible children patients,one group was prescribed amoxicillin,and another not.
- Conditions
- Acute Upper Respiratory Tract Infection
- Being tested
- Amoxicillin
- Keywords
- Non-antibiotic prescribing, acute upper respiratory tract infection, white cell count, vomiting
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
β-lactam antibiotics
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin | Active comparator | Amoxicillin were given to the children with acute upper respiratory tract infection characterized by fever and vomiting. Receives: Drug: Amoxicillin |
| control | No intervention | Non-antibiotics were given to the children with acute upper respiratory tract infection characterized by fever and vomiting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fever
Fever stopped or mitigated in 90% participants.
Measured: 3 days
Secondary outcomes (1)
vomiting
Vomiting stopped or mitigated in 90% participants.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study start1 Aug 2011
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Why it stopped: no patients were included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Upper Respiratory Tract InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Long Chen, MD, Principal investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930955
- Sponsor's protocol ID
- AURI
- Status last verified
- Feb 2021
- First submitted
- 20 Aug 2013
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection：a Randomized-control Trial
- ClinicalTrials.gov ID
- NCT01930955
- Acronym / sponsor ID
- AURI
- Conditions
- Acute Upper Respiratory Tract Infection
- Keywords
- Non-antibiotic prescribing, acute upper respiratory tract infection, white cell count, vomiting
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patients were included
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2011 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 29 Aug 2013 (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.
Some acute upper respiratory tract infection(AURI) in children is characterized by fever and vomiting,and it is one common reason for visiting a pediatrician. White blood count(WBC) usually increased in this children patients,hence antibiotics are often prescribed properly assumed. In the present study, it was hypothesized that it was not necessary to prescribe amoxicillin for the children.
Detailed description
After inclusion of eligible children patients,one group was prescribed amoxicillin,and another not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin | Active comparator | Drug: AmoxicillinAmoxicillin were given to the children with acute upper respiratory tract infection characterized by fever and vomiting. |
| control | No intervention | –Non-antibiotics were given to the children with acute upper respiratory tract infection characterized by fever and vomiting. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Acute upper respiratory tract infection
- Fever
- Vomiting
- Increased white blood cell
Key exclusion criteria (2 listed)
- 0ther symptoms of digestive system
- Headache
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 |
|---|---|---|
| Amoxicillinβ-lactam antibiotics | Drug | Amoxicillin |
Primary outcome
fever
Time frame: 3 days
Fever stopped or mitigated in 90% participants.
1 secondary outcome
vomiting
Time frame: 2 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
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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.
Long Chen, MD principal investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin in people with Acute Upper Respiratory Tract Infection, run by Daping Hospital and the Research Institute of Surgery of the Third Military 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 4 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: withdrawn, as of the sponsor's last update on 1 May 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
fever (time frame: 3 days). 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 1 May 2023.