Community Acquired Pneumonia in ChildrenPhase 4NCT06494072
Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP
A Phase 4 study testing Ampicillin for Injection, Ceftriaxone for Injection and Amoxicillin in people with Community Acquired Pneumonia in Children, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The goal of this open label, randomized, non-inferiority clinical trial is to compare the treatment success of a 5 day antibiotic course versus a standard antibiotic course (usually 7-14 days of antibiotics) in hospitalized children aged 3 months to 18 years, with uncomplicated community acquired pneumonia. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Community Acquired Pneumonia in Children
- What is being tested?
- Ampicillin for Injection, Ceftriaxone for Injection and Amoxicillin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2024to May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 3 months to <18 years old
- Hospitalized in either the acute care or the pediatric intensive care units
- Clinically diagnosed with uncomplicated bacterial community acquired pneumonia (as determined by the treating physician)
- Radiological findings suggestive of pneumonia (such as consolidation, lobar or interstitial infiltrates)
- Achieved clinical stability within 72 hours from the first antibiotic dose (clinical stability includes being off supplemental oxygen/ventilatory support and temperature remaining < 38 Celsius).
- Exclusion Criteria (presence of ANY of the following will exclude a potential participant):
Show all 22Show fewer
- Hemodynamic instability at any point during hospitalization that required inotropic support
- Requirement of respiratory support > 72 hours
- Presence of a parapneumonic effusion >10 mm on decubitus x-ray or greater than ¼ of hemithorax opacified on chest imaging
- Need for chest tube placement
- Extrapulmonary involvement (ie: another infection located outside of the lungs) except for otitis media if the planned treatment is ≤ 5 days
- Pneumonia caused by known staphylococcus aureus identified from culture (blood, bronchoalveolar aspirate, tracheal aspirate, or pleural fluid)
- Antibiotic course started >72 hours after admission
- Antibiotics used for > 24 hours within the 2 weeks prior to admission
- Chronic respiratory illness other than asthma or reactive airway disease
- Immunocompromised patient (primary or secondary)
- Primary physician refusal
- Parent refusal
- Non-English speakers
- Pregnant or lactating female
- Participant will become ≥ 18 years old at or before the time of day 14 follow up
- Inability to adhere to follow up
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Childrens Wisconsin
Milwaukee, Wisconsin, 53226
Michelle Mitchell, MD, 4143377070, mimitchell@mcw.edu
Michelle Mitchell, MD
About this study
Official title: Short Versus Standard of Care Antibiotic Duration for Hospitalized Children With Uncomplicated Community-acquired Pneumonia: a Non-inferiority, Randomized Controlled Trial.
The goal of this open label, randomized, non-inferiority clinical trial is to compare the treatment success of a 5 day antibiotic course versus a standard antibiotic course (usually 7-14 days of antibiotics) in hospitalized children aged 3 months to 18 years, with uncomplicated community acquired pneumonia.
The main questions it aims to answer are:
Read more
- Does a 5 day course work as well as standard (longer) courses of antibiotics for treating community acquired pneumonia in children?
- Does a 5 day course cause less antibiotic side effects compared to a standard (longer) course of antibiotics in children with community acquired pneumonia?
Participants will
- be randomly assigned to either receive 5 total days or a total duration decided by the treating physician
- receive a brief follow up questionnaire regarding clinical symptoms, follow up care/antibiotics, and side effects via phone or email at days 5 and 14 from the start of antibiotics
Researchers will compare the experimental group (receiving 5 days duration) with the control group (standard duration) to see if 5 days is as successful as a standard duration.
Read the detailed description
This is an open label, randomized, non-inferiority clinical trial to determine if a 5-day antibiotic course works as well compared to a standard antibiotic course (usually 7-10 days of antibiotics) in hospitalized children who are aged 3 months to less than 18 years old, with uncomplicated community acquired pneumonia.
We will recruit 150 participants meeting inclusion/exclusion criteria. Participants will be randomized to one of the study groups. In the experimental group, the participant will receive a total antibiotic course of 5 days. In the other group (control group), participants will receive the standard-of-care antibiotic course (the duration will be decided by the primary treating physician in this group). The selection of antibiotic therapy will be made by the treating physician, generally in accordance with the institutional clinical practice guideline on community acquired pneumonia, prior to enrollment in the study. Other medical care, aside from the treatment duration, will be the same and will be guided by the primary treating doctor. The primary treating doctor will also decide when the participant is medically ready for discharge from the hospital.
During the consenting process, a member of the research team will verify the contact numbers or email of the parent(s)/guardian of participant to be used after discharge for follow-up communication. Every participant's parent/guardian will receive a text message/email questionnaire on day 5 and day 14 after the start of antibiotics to assess for clinical improvement, side effect(s) to the antibiotics, recurrence of fever, or need for additional antibiotics or other medical care. Participants parent(s)/guardian will be contacted by phone for additional information if there is concern for a failure or significant medical concern.
The primary objective of this study is to compare the failure rate between a short course (5-days) and standard antibiotic course (usually 7-10 days of antibiotics) of antibiotics in hospitalized children with uncomplicated pneumonia. Failure will be defined as the clinical need for additional antibiotic treatment, emergency department visit or readmission to the hospital for a suspected lower respiratory tract infection within 14 days of treatment initiation.
The secondary objective will compare the rate of adverse drug events between short and long-course durations of antibiotic therapy in children hospitalized for CAP. Adverse drug events include any allergic reaction such as skin rash, itching or other and/or abdominal symptoms such as vomiting, stomach pain and diarrhea.
Data will be summarized by n (%) or mean and standard deviation (SD) or median and interquartile range (IQR). Continuous variables will be compared by t-test while categorical variables will be compared by Chi-square or Fisher's exact test. A 95% CI will be calculated for the difference in failure rate between the shorter antibiotic course (5-day) group and the standard course group. Non-inferiority will be declared if the 95% CI lies below 10%. P<0.05 will be considered statistically significant. Data will be analyzed by SAS version 9.4 (SAS Institute Inc., Cary, NC) and SPSS version 28.0 (IBM Corp., Armonk, NY).
- Conditions
- Community Acquired Pneumonia in Children
- Being tested
- Ampicillin for Injection, Ceftriaxone for Injection, Amoxicillin, Ampicillin / Sulbactam Injection, Amoxicillin-clavulanate
- Keywords
- inpatient, pediatric, hospitalized, community acquired pneumonia., antibiotic duration
- 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.
Ampicillin for InjectionDrug
Ampicillin is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.
Ceftriaxone for InjectionDrug
Also called Rocephin
Ceftriaxone is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.
AmoxicillinDrug
Amoxicillin is an oral antibiotic commonly used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge.
Ampicillin / Sulbactam InjectionDrug
Also called Unasyn
Ampicillin/Sulbactam is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.
Amoxicillin-clavulanateDrug
Also called Augmentin
Amoxicillin-clavulanate is an oral antibiotic commonly used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge.
ClindamycinDrug
Also called Cleocin
Clindamycin is an antibiotic that can be given intravenously or orally that is sometimes used in the treatment of children hospitalized or discharged with community-acquired pneumonia.
CefprozilDrug
Also called Cefzil
Cefprozil is an oral antibiotic sometimes used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge.
LevofloxacinDrug
Also called Levaquin
Levofloxacin is an antibiotic that can be given intravenously or orally that is sometimes used in the treatment of children hospitalized or discharged with community-acquired pneumonia.
| Study group | Role | What they receive |
|---|---|---|
| Short course antibiotic duration | Experimental | The participants in this group will receive a total antibiotic course of 5 days including the number of days received during their hospital admission and following hospital admission combined. Receives: Drug: Ampicillin for Injection; Drug: Ceftriaxone for Injection; Drug: Amoxicillin; Drug: Ampicillin / Sulbactam Injection; Drug: Amoxicillin-clavulanate; Drug: Clindamycin; Drug: Cefprozil; Drug: Levofloxacin |
| Standard of care antibiotic duration | Active comparator | Participants will receive the standard-of-care antibiotic course in this group. That is, the duration of antibiotics will be decided by the primary treating physician in this group. The antibiotic course will include the number of days received during the participant's hospital admission and following hospital admission combined. Receives: Drug: Ampicillin for Injection; Drug: Ceftriaxone for Injection; Drug: Amoxicillin; Drug: Ampicillin / Sulbactam Injection; Drug: Amoxicillin-clavulanate; Drug: Clindamycin; Drug: Cefprozil; Drug: Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure rate
Treatment failure is defined as the clinical need for additional antibiotic treatment, an emergency department (ED) visit, or readmission to the hospital for a suspected lower respiratory tract infection within 14 days of treatment initiation.
Measured: 14 days from the first dose antibiotics
Secondary outcomes (1)
Adverse drug event rate
Adverse drug events include allergic reactions, skin rash, abdominal symptoms (such as vomiting, stomach pain, or diarrhea), or other plausible associated complaints described by the parent(s)/guardian.
Measured: 14 days from the first dose antibiotics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start22 Aug 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired Pneumonia in ChildrenStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of short duration (5 days) versus a standard of care duration of antibiotics on the effective treatment of children hospitalized for uncomplicated community acquired pneumonia.
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Mitchell, Medical College of Wisconsin
- Investigators
- Michelle Mitchell, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494072
- Sponsor's protocol ID
- PRO00046965
- Status last verified
- Feb 2026
- First submitted
- 2 Jul 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregated data results will be provided.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Versus Standard of Care Antibiotic Duration for Hospitalized Children With Uncomplicated Community-acquired Pneumonia: a Non-inferiority, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06494072
- Acronym / sponsor ID
- PRO00046965
- Conditions
- Community Acquired Pneumonia in Children
- Keywords
- inpatient, pediatric, hospitalized, community acquired pneumonia., antibiotic duration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 10 Jul 2024 (actual)
- 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.
The goal of this open label, randomized, non-inferiority clinical trial is to compare the treatment success of a 5 day antibiotic course versus a standard antibiotic course (usually 7-14 days of antibiotics) in hospitalized children aged 3 months to 18 years, with uncomplicated community acquired pneumonia.
The main questions it aims to answer are:
- Does a 5 day course work as well as standard (longer) courses of antibiotics for treating community acquired pneumonia in children?
- Does a 5 day course cause less antibiotic side effects compared to a standard (longer) course of antibiotics in children with community acquired pneumonia?
Participants will
- be randomly assigned to either receive 5 total days or a total duration decided by the treating physician
- receive a brief follow up questionnaire regarding clinical symptoms, follow up care/antibiotics, and side effects via phone or email at days 5 and 14 from the start of antibiotics
Researchers will compare the experimental group (receiving 5 days duration) with the control group (standard duration) to see if 5 days is as successful as a standard duration.
Detailed description
This is an open label, randomized, non-inferiority clinical trial to determine if a 5-day antibiotic course works as well compared to a standard antibiotic course (usually 7-10 days of antibiotics) in hospitalized children who are aged 3 months to less than 18 years old, with uncomplicated community acquired pneumonia.
We will recruit 150 participants meeting inclusion/exclusion criteria. Participants will be randomized to one of the study groups. In the experimental group, the participant will receive a total antibiotic course of 5 days. In the other group (control group), participants will receive the standard-of-care antibiotic course (the duration will be decided by the primary treating physician in this group). The selection of antibiotic therapy will be made by the treating physician, generally in accordance with the institutional clinical practice guideline on community acquired pneumonia, prior to enrollment in the study. Other medical care, aside from the treatment duration, will be the same and will be guided by the primary treating doctor. The primary treating doctor will also decide when the participant is medically ready for discharge from the hospital.
During the consenting process, a member of the research team will verify the contact numbers or email of the parent(s)/guardian of participant to be used after discharge for follow-up communication. Every participant's parent/guardian will receive a text message/email questionnaire on day 5 and day 14 after the start of antibiotics to assess for clinical improvement, side effect(s) to the antibiotics, recurrence of fever, or need for additional antibiotics or other medical care. Participants parent(s)/guardian will be contacted by phone for additional information if there is concern for a failure or significant medical concern.
The primary objective of this study is to compare the failure rate between a short course (5-days) and standard antibiotic course (usually 7-10 days of antibiotics) of antibiotics in hospitalized children with uncomplicated pneumonia. Failure will be defined as the clinical need for additional antibiotic treatment, emergency department visit or readmission to the hospital for a suspected lower respiratory tract infection within 14 days of treatment initiation.
The secondary objective will compare the rate of adverse drug events between short and long-course durations of antibiotic therapy in children hospitalized for CAP. Adverse drug events include any allergic reaction such as skin rash, itching or other and/or abdominal symptoms such as vomiting, stomach pain and diarrhea.
Data will be summarized by n (%) or mean and standard deviation (SD) or median and interquartile range (IQR). Continuous variables will be compared by t-test while categorical variables will be compared by Chi-square or Fisher's exact test. A 95% CI will be calculated for the difference in failure rate between the shorter antibiotic course (5-day) group and the standard course group. Non-inferiority will be declared if the 95% CI lies below 10%. P<0.05 will be considered statistically significant. Data will be analyzed by SAS version 9.4 (SAS Institute Inc., Cary, NC) and SPSS version 28.0 (IBM Corp., Armonk, NY).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of short duration (5 days) versus a standard of care duration of antibiotics on the effective treatment of children hospitalized for uncomplicated community acquired pneumonia.
| Arm | Type | Receives |
|---|---|---|
| Short course antibiotic duration | Experimental | Drug: Ampicillin for Injection, Drug: Ceftriaxone for Injection, Drug: Amoxicillin, Drug: Ampicillin / Sulbactam Injection, Drug: Amoxicillin-clavulanate, Drug: Clindamycin, Drug: Cefprozil, Drug: LevofloxacinThe participants in this group will receive a total antibiotic course of 5 days including the number of days received during their hospital admission and following hospital admission combined. |
| Standard of care antibiotic duration | Active comparator | Drug: Ampicillin for Injection, Drug: Ceftriaxone for Injection, Drug: Amoxicillin, Drug: Ampicillin / Sulbactam Injection, Drug: Amoxicillin-clavulanate, Drug: Clindamycin, Drug: Cefprozil, Drug: LevofloxacinParticipants will receive the standard-of-care antibiotic course in this group. That is, the duration of antibiotics will be decided by the primary treating physician in this group. The antibiotic course will include the number of days received during the participant's hospital admission and following hospital admission combined. |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (22 listed)
- Children aged 3 months to <18 years old
- Hospitalized in either the acute care or the pediatric intensive care units
- Clinically diagnosed with uncomplicated bacterial community acquired pneumonia (as determined by the treating physician)
- Radiological findings suggestive of pneumonia (such as consolidation, lobar or interstitial infiltrates)
- Achieved clinical stability within 72 hours from the first antibiotic dose (clinical stability includes being off supplemental oxygen/ventilatory support and temperature remaining < 38 Celsius).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ampicillin for InjectionAmpicillin is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia. | Drug | Short course antibiotic duration, Standard of care antibiotic duration |
| Ceftriaxone for InjectionAlso: RocephinCeftriaxone is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia. | Drug | Short course antibiotic duration, Standard of care antibiotic duration |
| AmoxicillinAmoxicillin is an oral antibiotic commonly used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge. | Drug | Short course antibiotic duration, Standard of care antibiotic duration |
| Ampicillin / Sulbactam InjectionAlso: UnasynAmpicillin/Sulbactam is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia. | Drug | Short course antibiotic duration, Standard of care antibiotic duration |
| Amoxicillin-clavulanateAlso: AugmentinAmoxicillin-clavulanate is an oral antibiotic commonly used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge. | Drug | Short course antibiotic duration, Standard of care antibiotic duration |
| ClindamycinAlso: CleocinClindamycin is an antibiotic that can be given intravenously or orally that is sometimes used in the treatment of children hospitalized or discharged with community-acquired pneumonia. | Drug | Short course antibiotic duration, Standard of care antibiotic duration |
| CefprozilAlso: CefzilCefprozil is an oral antibiotic sometimes used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge. | Drug | Short course antibiotic duration, Standard of care antibiotic duration |
| LevofloxacinAlso: LevaquinLevofloxacin is an antibiotic that can be given intravenously or orally that is sometimes used in the treatment of children hospitalized or discharged with community-acquired pneumonia. | Drug | Short course antibiotic duration, Standard of care antibiotic duration |
Primary outcome
Treatment failure rate
Time frame: 14 days from the first dose antibiotics
Treatment failure is defined as the clinical need for additional antibiotic treatment, an emergency department (ED) visit, or readmission to the hospital for a suspected lower respiratory tract infection within 14 days of treatment initiation.
1 secondary outcome
Adverse drug event rate
Time frame: 14 days from the first dose antibiotics
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No. Aggregated data results will be provided.
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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.
Michelle Mitchell principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ampicillin for Injection, Ceftriaxone for Injection and Amoxicillin in people with Community Acquired Pneumonia in Children, run by Medical College of Wisconsin at 1 site in United States.
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 22 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 2 Mar 2026. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Mitchell, MD (414-337-7070, mimitchell@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure rate (time frame: 14 days from the first dose antibiotics). 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 2 Mar 2026.