Clinical Stability Assessment for Pneumonia in Children

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Boston Children's Hospital

Must be taking: Antibiotics

Disqualifiers: Intermediate care, ICU admission

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

To determine if clinicians can safely reduce antibiotic exposure in children with medical complexity (CMC) who are diagnosed with pneumonia by implementing an intervention that bases total antibiotic duration on an individual's clinical stability.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on adjusting antibiotic use based on clinical stability.

What data supports the effectiveness of the drug PatIent Centered ANtIbiotic Courses for treating pneumonia in children?

Research shows that timely administration of antibiotics in children with pneumonia is linked to faster recovery and shorter hospital stays. Delays in starting antibiotics can increase the time it takes for children to become stable and extend their hospital stay. ^{1 2 3 4 5}

Is the treatment generally safe for children?

Research shows that antibiotics, often used for various conditions in children, can cause adverse reactions. For example, one study found that 51% of antibiotic courses in children led to adverse events, and some antibiotics like vancomycin had high rates of side effects. However, others like cefazolin had lower rates of adverse events. ^{6 7 8 9 10}

How is the drug PatIent Centered ANtIbiotic Courses different from other treatments for pneumonia in children?

This treatment focuses on tailoring the length of antibiotic courses to the individual needs of children with pneumonia, potentially using shorter courses compared to traditional longer treatments, which can help reduce side effects and antibiotic resistance. ^{3 11 12 13 14}

Research Team

Eligibility Criteria

The PICNIC Study is for children and young adults aged 2-25 with complex medical conditions who are diagnosed with pneumonia. They must have started antibiotics and be admitted to the Complex Care Service at Boston Children's Hospital.

Inclusion Criteria

My doctor has started me on antibiotics.

I am between 2 and 25 years old.

I am admitted to Boston Children's Hospital for pneumonia.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive antibiotics for pneumonia, with daily monitoring until clinically stable for 48 hours

Variable, based on clinical stability

Follow-up

Participants are monitored for safety and effectiveness after treatment, including rate of emergency department revisit or hospital readmission

1 week

Treatment Details

Interventions

• PatIent Centered ANtIbiotic Courses (Anti-biotic)

Trial Overview The study tests if doctors can safely shorten antibiotic use in these patients by deciding how long to treat based on when the patient starts getting better, rather than a set number of days.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

Patients will be started on antibiotics for treatment of pneumonia per usual care by their medical provider team. The research team will monitor enrolled patients daily for markers of their clinical status (caregiver assessment of respiratory status, supplemental oxygen/respiratory support, presence of fever). Once the patient has been "clinically stable" x48 hours, antibiotics will be discontinued.

PatIent Centered ANtIbiotic Courses is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Antibiotics for:

• Bacterial infections
• Pneumonia
• Urinary tract infections

Approved in Japan as Antibiotics for:

• Bacterial infections
• Pneumonia
• Urinary tract infections

Approved in China as Antibiotics for:

• Bacterial infections
• Pneumonia
• Urinary tract infections

Approved in Switzerland as Antibiotics for:

• Bacterial infections
• Pneumonia
• Urinary tract infections

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Dr. Kevin B. Churchwell

Boston Children's Hospital

Chief Executive Officer since 2021

MD from Vanderbilt Medical School

Dr. Sarah Pitts

Boston Children's Hospital

Chief Medical Officer since 2019

MD from Harvard Medical School

Findings from Research

Evaluating clinical outcomes after starting antibiotics in patients with community-acquired pneumonia (CAP) is crucial for determining treatment steps, such as switching from intravenous to oral antibiotics and deciding on patient discharge.

Identifying the reasons for treatment or clinical failure in CAP patients is essential for improving care and preventing adverse outcomes, highlighting the need for better understanding of nonresolving pneumonia and its associated risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical stability versus clinical failure in patients with community-acquired pneumonia. Aliberti, S., Blasi, F.[2012]

In outpatient settings, around 80% of patients with community-acquired pneumonia are treated, highlighting the importance of effective treatment strategies for this population.

Patient-reported outcomes and time to clinical endpoints are valid and reproducible measures that can be used in clinical trials to assess the safety and efficacy of antibacterial treatments for mild-to-moderate community-acquired pneumonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical end points of therapy for patients with mild community-acquired pneumonia. Gilbert, DN.[2015]

In a study of children admitted with community-acquired pneumonia (CAP), most met quality indicators for rapid oxygen assessment (97%) and blood culture before antibiotics (98%), but indicators for antibiotic timing and selection were less frequently achieved.

The timing of antibiotic administration was crucial; each additional hour delay in giving antibiotics increased the time to clinical stability and length of hospital stay by 3%, highlighting the need for improved antibiotic timing in pediatric CAP management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing quality indicators for pediatric community-acquired pneumonia. Sandora, TJ., Desai, R., Miko, BA., et al.[2019]

In a study of 42,452 pediatric cases of community-acquired pneumonia (CAP), 76% resulted in antibiotic prescriptions, with amoxicillin being the most commonly prescribed agent (51%).

Only 27% of antibiotic prescriptions adhered to guidelines, highlighting a significant opportunity for improvement in prescribing practices, particularly in reducing unnecessary treatment durations and ensuring appropriate dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of antibiotic prescribing for pediatric community-acquired Pneumonia in outpatient care. Saatchi, A., Haverkate, MR., Reid, JN., et al.[2023]

A study of 893 children hospitalized for community-acquired pneumonia showed that empiric antibiotic therapy remained effective over the years 1991-2001, despite a significant increase in antibiotic failure rates from 3.8% to 11.4%.

The increase in antibiotic failure was attributed to inadequate coverage in the earlier years and presumed antibiotic resistance in the later years, highlighting the need for ongoing evaluation of antibiotic effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empiric antibiotic therapy in children with community-acquired pneumonia. Zhang, L., Lovatel, R., Nicolete, D., et al.[2014]

In a study of 335 pediatric patients receiving prolonged outpatient antimicrobials, 31.9% experienced adverse events (AEs), with diarrhea being the most common, affecting 29.1% of all AEs.

Serious AEs occurred in 12.5% of subjects, highlighting the importance of close monitoring for potential complications, such as allergic reactions and neutropenia, during extended antimicrobial therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events in Pediatric Patients Receiving Long-Term Outpatient Antimicrobials. Olson, SC., Smith, S., Weissman, SJ., et al.[2022]

In a study of 192 children aged 2 to 59 months with nonsevere pneumonia treated with amoxicillin, the clinical failure rate was low at 2.6%, indicating that amoxicillin is generally effective for this condition.

Adverse effects were reported in 7.3% of cases, but only one child (0.5%) discontinued treatment due to these effects, suggesting that amoxicillin is safe for use in young children with pneumonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical failure among children with nonsevere community-acquired pneumonia treated with amoxicillin. Fontoura, MS., Araújo-Neto, CA., Andrade, SC., et al.[2013]

In a study involving 576 healthcare professionals in Greece, 44.8% of nurses and 23.7% of doctors reported that adverse drug reactions (ADRs) from antibiotics occur frequently in pediatric patients, highlighting the importance of monitoring these reactions.

Despite the prevalence of ADRs, a significant number of healthcare providers (63% of nurses and 32.7% of doctors) reported never having documented any ADRs, indicating a serious issue with underreporting in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reaction reporting related to the administration of antibiotics in hospitalized pediatric patients in Greece. Toska, A., Mary, G., Kyriakos, S., et al.[2019]

In a study of 45 children receiving outpatient parenteral antibiotic therapy, over half (51%) of the antibiotic courses led to adverse drug events (ADE), with 32.5% of courses being discontinued due to these events.

Vancomycin was associated with the highest rate of ADEs at 85.7%, while ceftriaxone had the highest discontinuation rate due to ADEs at 66.7%, whereas cefazolin showed no ADEs or discontinuations, indicating it may be a safer option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The high rate of adverse drug events in children receiving prolonged outpatient parenteral antibiotic therapy for osteomyelitis. Faden, D., Faden, HS.[2009]

In a study analyzing 338 reports of anti-infective medication errors in pediatric patients, 13.6% of these errors reached the patients, with 1.5% resulting in harm that required additional medical intervention.

The majority of errors involved antibacterials, particularly beta-lactams, indicating that certain classes of anti-infective medications carry a higher risk of harmful errors, highlighting the need for improved safety measures in prescribing and administering these drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology of and Risk Factors for Harmful Anti-Infective Medication Errors in a Pediatric Hospital. Modi, A., Germain, E., Soma, V., et al.[2022]

A systematic review and meta-analysis of studies comparing short-course and long-course antibiotic therapy for children with nonsevere community-acquired pneumonia found that short-course therapy is equally effective in treating the condition.

The analysis suggests that shorter antibiotic treatments may reduce the risk of antibiotic resistance and side effects, making them a safer option for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic course length for pneumonia in young children. [2023]

In a study of 1163 children with community-acquired bacterial pneumonia, the use of standardized antimicrobial guidelines led to a high compliance rate (93%) and effective treatment outcomes, even in cases of empyema and penicillin-resistant Streptococcus pneumoniae.

The majority of identified S. pneumoniae strains were susceptible to penicillin, indicating that penicillin resistance is not a significant issue for pediatric pneumonia in Uruguay, but ongoing surveillance of bacterial resistance is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standard case management of pneumonia in hospitalized children in Uruguay, 1997 to 1998. Pírez, MC., Martínez, O., Ferrari, AM., et al.[2019]

Children under 2 months with community-acquired pneumonia should always be hospitalized and treated with ampicillin and aminoglycosides or third-generation cephalosporins, while those older than 2 months may be treated outpatient with amoxicillin or penicillin G procaine unless severe symptoms are present.

The study emphasizes that pneumonia severity can be assessed clinically, with specific antibiotics recommended based on age and severity, including options like crystalline penicillin and ceftriaxone for severe cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Recommendation of the Brazilian Society of Pediatrics for antibiotic therapy in children and adolescents with community-acquired pneumonia]. Nascimento-Carvalho, CM., Souza-Marques, HH.[2019]

Streptococcus pneumoniae and Haemophilus influenzae are the most common causes of community-acquired pneumonia in children, but increasing antibiotic resistance has led to a need for updated treatment strategies.

Amoxicillin and oral cephalosporins are recommended for mild to moderate cases, while severe cases may require extended spectrum cephalosporins or vancomycin; new macrolides like azithromycin and clarithromycin offer effective options for mycoplasma pneumonia, allowing for outpatient treatment and reducing the need for hospital admissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antimicrobial therapy of pneumonia in infants and children. Harris, JA.[2004]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical stability versus clinical failure in patients with community-acquired pneumonia. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical end points of therapy for patients with mild community-acquired pneumonia. [2015]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Assessing quality indicators for pediatric community-acquired pneumonia. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Quality of antibiotic prescribing for pediatric community-acquired Pneumonia in outpatient care. [2023]

5. India pubmed.ncbi.nlm.nih.gov

Empiric antibiotic therapy in children with community-acquired pneumonia. [2014]

6. England pubmed.ncbi.nlm.nih.gov

Adverse Events in Pediatric Patients Receiving Long-Term Outpatient Antimicrobials. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Clinical failure among children with nonsevere community-acquired pneumonia treated with amoxicillin. [2013]

8. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Adverse drug reaction reporting related to the administration of antibiotics in hospitalized pediatric patients in Greece. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The high rate of adverse drug events in children receiving prolonged outpatient parenteral antibiotic therapy for osteomyelitis. [2009]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Epidemiology of and Risk Factors for Harmful Anti-Infective Medication Errors in a Pediatric Hospital. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Antibiotic course length for pneumonia in young children. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Standard case management of pneumonia in hospitalized children in Uruguay, 1997 to 1998. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

[Recommendation of the Brazilian Society of Pediatrics for antibiotic therapy in children and adolescents with community-acquired pneumonia]. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Antimicrobial therapy of pneumonia in infants and children. [2004]