PneumoniaEarly Phase 1STAMPPNCT05726253
Supportive Treatment and Antibiotics for Mild Pediatric Pneumonia
A Early Phase 1 study testing Supportive Care + Amoxicillin in people with Pneumonia and Pediatric Respiratory Diseases, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
National guidelines make two recommendations for treatment of young children with mild pneumonia - one to avoid routine antibiotics and another to use narrow-spectrum antibiotics. No studies have compared the effectiveness of these two approaches. Read more about this study
- Who is it for?
- Ages 12 to 71 months
- Conditions the study is for
- Pneumonia, Pediatric Respiratory Diseases, Antibiotic Use
- What is being tested?
- Supportive Care + Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 31 Dec 2023
- Phase
- Early Phase 1
- 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 12 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 12-71 months; and
- Diagnosis of CAP, defined using established criteria:
- Signs and symptoms of lower respiratory tract infection (LRTI), defined as any of the following:
- new or different cough; or
- new or different sputum production; or
- chest pain; or
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- dyspnea/shortness of breath; or
- documented tachypnea; or
- abnormal findings consistent with LRTI on physical examination (e.g., crackles/rales, rhonchi, wheezing) and
- Fever, defined as tactile temperature at home or measured temperature ≥38ºC rectal, ≥37.7ºC oral, or ≥37.5ºC axillary, and
- Clinician diagnosis of CAP,
- Intention to treat as an outpatient after ED/primary care visit, and
- Mild disease, defined as lack of respiratory distress per adapted Pediatric Infectious Diseases Society/Infectious Diseases Society of America criteria: none of the following: dyspnea, concerning retractions per treating clinician, grunting, nasal flaring, apnea, altered mental status, SpO2<93% in room air, or respiratory rate >50 breaths per minute for ages 12-24 months or respiratory rate > 40 breaths per minute if age>24 months.
Who cannot join
- Hospitalization within one-month preceding study visit; or
- Incomplete immunization status (<2 doses of Hib and pneumococcal vaccines); or
- Chronic complex medical conditions (chronic heart disease followed by cardiology, chronic lung disease (not including asthma), congenital airway or lung malformations, cystic fibrosis, tracheostomy tube, requiring positive-pressure ventilation, neuromuscular disorders affecting the lungs or chest wall); or
- Conditions that compromise the immune system (HIV with CD4 count less than 400, primary immunodeficiency, asplenia, sickle cell disease, receipt of hematopoietic stem cell or solid organ transplant, cancer on active chemotherapy, immunosuppressive agents, daily corticosteroids for more than 7 consecutive days in past 14 days); or
- Systemic antibiotic receipt (more than 1 dose) within the previous two weeks of CAP diagnosis; or
- Radiographic findings of a consolidation of a concerning size or complexity in the view of the treating clinician; or
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- Radiographic findings of complicated pneumonia (pleural effusion larger than trace in size, empyema, [complex/septated collection] abscess, necrotic lung disease); or
- Pneumonia known to be due to bacterial source at the time of enrollment, as documented by blood culture or PCR if available, or another clear source of bacterial infection requiring immediate antibiotics; or
- Diagnosed with pneumonia in the previous month; or
- Provider diagnosis of aspiration pneumonia; or
- Severe (type 1) drug allergy to amoxicillin; or
- Any other condition that in the judgement of investigators or the clinical team could affect safety of the subject; or
- No access to a telephone or video technology for follow-up; or
- Current enrollment in another clinical trial of an investigational agent; or
- Previous enrollment in this trial; or
- Parent/guardian non-English or non-Spanish speaking; or
- Known allergy to milk and/or red dye.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60610
About this study
National guidelines make two recommendations for treatment of young children with mild pneumonia - one to avoid routine antibiotics and another to use narrow-spectrum antibiotics. No studies have compared the effectiveness of these two approaches. This pilot study will evaluate study processes and feasibility of a future clinical trial that proposes to test whether low-risk children managed as outpatients with mild community-acquired pneumonia (CAP) treated with supportive treatment without antibiotics will have a similar clinical response, with fewer adverse effects, compared with those treated with a supportive treatment plan that includes antibiotics.
Read the detailed description
This pilot clinical trial is a randomized, placebo-controlled, double-blinded trial assessing the feasibility of comparing supportive care+amoxicillin to supportive care without antibiotics (i.e., placebo) in children 12 months to <6 years of age who present to the ED with community-acquired pneumonia (CAP) and who will be treated as outpatients.
This trial will enroll over a 6-month period and take place at Ann and Robert H. Lurie Children's Hospital of Chicago. Clinical research coordinators (CRCs) will screen for and enroll eligible children.
Through an online system, participants will be randomized to a 7-day course of either amoxicillin (80-100 mg/kg divided BID up to 4,000 mg/day) or matching placebo. All patients will receive a supportive care treatment bundle that includes antipyretics, honey, and saline spray, in addition to instructions on how to manage lower respiratory infections.
The guardians of participants will be asked to complete an online daily symptom diary during the first 6 days after the initial study visit. Participants will have daily telehealth evaluations by clinicians for the first three days after the index study visit. The primary outcome will be assessed at day 7, using telehealth technology. A final follow-up, performed by site research staff, by telephone call, will occur at Day 21 to assess overall disease course and secondary outcomes.
- Being tested
- Supportive Care + Amoxicillin, Supportive Care + Placebo (no antibiotics)
- Keywords
- Pediatrics, Pediatric CAP, Pediatric Pneumonia, Antibiotic Use
- Medical subject headings
- Pneumonia, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive Care + AmoxicillinDrug
Participants will be randomized to receive oral amoxicillin for a standard course (7 days)
Supportive Care + Placebo (no antibiotics)Drug
Participants will be randomized to receive oral placebo for a standard course (7 days)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Randomization to receive either oral placebo or amoxicillin for a standard course (7 days) Receives: Drug: Supportive Care + Placebo (no antibiotics) |
| Amoxicillin | Active comparator | Randomization to receive either oral amoxicillin or placebo for a standard course (7 days) Receives: Drug: Supportive Care + Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate Per Month
Total number of participants enrolled divided by the total number of active enrollment months
Measured: Measured at completion of pilot trial (6 months)
Secondary outcomes (3)
Consent Rate
Number of eligible participants approached regarding trial participation who provided informed consent to participate in the trial compared with number of participants approached for participation
Measured: Measured at completion of pilot trial (6 months)
Lost to Follow-Up at Day 7
Number of enrolled participants who did not complete the Day 7 follow-up visit
Measured: Measured at completion of pilot trial (6 months)
Lost to Follow-Up at Day 21
Number of enrolled participants who did not complete the Day 21 follow-up visit
Measured: Measured at completion of pilot trial (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start9 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot Feasibility Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726253
- Sponsor's protocol ID
- 2023-5696
- Acronym
- STAMPP
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: As this is a pilot study, a public use dataset will not be developed.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive Treatment and Antibiotics for Mild Pediatric Pneumonia
- ClinicalTrials.gov ID
- NCT05726253
- Acronym / sponsor ID
- STAMPP / 2023-5696
- Keywords
- Pediatrics, Pediatric CAP, Pediatric Pneumonia, Antibiotic Use
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Feb 2023 (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.
National guidelines make two recommendations for treatment of young children with mild pneumonia - one to avoid routine antibiotics and another to use narrow-spectrum antibiotics. No studies have compared the effectiveness of these two approaches. This pilot study will evaluate study processes and feasibility of a future clinical trial that proposes to test whether low-risk children managed as outpatients with mild community-acquired pneumonia (CAP) treated with supportive treatment without antibiotics will have a similar clinical response, with fewer adverse effects, compared with those treated with a supportive treatment plan that includes antibiotics.
Detailed description
This pilot clinical trial is a randomized, placebo-controlled, double-blinded trial assessing the feasibility of comparing supportive care+amoxicillin to supportive care without antibiotics (i.e., placebo) in children 12 months to <6 years of age who present to the ED with community-acquired pneumonia (CAP) and who will be treated as outpatients.
This trial will enroll over a 6-month period and take place at Ann and Robert H. Lurie Children's Hospital of Chicago. Clinical research coordinators (CRCs) will screen for and enroll eligible children.
Through an online system, participants will be randomized to a 7-day course of either amoxicillin (80-100 mg/kg divided BID up to 4,000 mg/day) or matching placebo. All patients will receive a supportive care treatment bundle that includes antipyretics, honey, and saline spray, in addition to instructions on how to manage lower respiratory infections.
The guardians of participants will be asked to complete an online daily symptom diary during the first 6 days after the initial study visit. Participants will have daily telehealth evaluations by clinicians for the first three days after the index study visit. The primary outcome will be assessed at day 7, using telehealth technology. A final follow-up, performed by site research staff, by telephone call, will occur at Day 21 to assess overall disease course and secondary outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot Feasibility Trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Supportive Care + Placebo (no antibiotics)Randomization to receive either oral placebo or amoxicillin for a standard course (7 days) |
| Amoxicillin | Active comparator | Drug: Supportive Care + AmoxicillinRandomization to receive either oral amoxicillin or placebo for a standard course (7 days) |
Who may qualify
- Ages
- 12 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Age 12-71 months; and
- Diagnosis of CAP, defined using established criteria:
- Intention to treat as an outpatient after ED/primary care visit, and
- Mild disease, defined as lack of respiratory distress per adapted Pediatric Infectious Diseases Society/Infectious Diseases Society of America criteria: none of the following: dyspnea, concerning retractions per treating clinician, grunting, nasal flaring, apnea, altered mental status, SpO2<93% in room air, or respiratory rate >50 breaths per minute for ages 12-24 months or respiratory rate > 40 breaths per minute if age>24 months.
Key exclusion criteria (17 listed)
- Hospitalization within one-month preceding study visit; or
- Incomplete immunization status (<2 doses of Hib and pneumococcal vaccines); or
- Chronic complex medical conditions (chronic heart disease followed by cardiology, chronic lung disease (not including asthma), congenital airway or lung malformations, cystic fibrosis, tracheostomy tube, requiring positive-pressure ventilation, neuromuscular disorders affecting the lungs or chest wall); or
- Conditions that compromise the immune system (HIV with CD4 count less than 400, primary immunodeficiency, asplenia, sickle cell disease, receipt of hematopoietic stem cell or solid organ transplant, cancer on active chemotherapy, immunosuppressive agents, daily corticosteroids for more than 7 consecutive days in past 14 days); or
- Systemic antibiotic receipt (more than 1 dose) within the previous two weeks of CAP diagnosis; or
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 |
|---|---|---|
| Supportive Care + AmoxicillinParticipants will be randomized to receive oral amoxicillin for a standard course (7 days) | Drug | Amoxicillin |
| Supportive Care + Placebo (no antibiotics)Participants will be randomized to receive oral placebo for a standard course (7 days) | Drug | Placebo |
Primary outcome
Enrollment Rate Per Month
Time frame: Measured at completion of pilot trial (6 months)
Total number of participants enrolled divided by the total number of active enrollment months
3 secondary outcomes
Consent Rate
Time frame: Measured at completion of pilot trial (6 months)
Lost to Follow-Up at Day 7
Time frame: Measured at completion of pilot trial (6 months)
Lost to Follow-Up at Day 21
Time frame: Measured at completion of pilot trial (6 months)
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 15 Feb 2024.
- Individual participant dataSharing planned: No. As this is a pilot study, a public use dataset will not be developed.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Supportive Care + Amoxicillin in people with Pneumonia and Pediatric Respiratory Diseases, run by Ann & Robert H Lurie Children's Hospital of Chicago 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 13 inclusion and 17 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 15 Feb 2024. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Enrollment Rate Per Month (time frame: Measured at completion of pilot trial (6 months)). 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 15 Feb 2024.