A Phase 4 Double Blinded Study With Two Different Interventions, Each With Two Arms, to Evaluate the Clinical Efficacy of Antibiotics and the Role of Microbiology, Immunology and Genetics in Children Aged 9-36 Months With Chronic Wet Cough.

The AMIC study is a double-blind, placebo-controlled, multicenter, nationwide, randomized controlled academic pharmaceutical trial.
OVERALL PRIMARY OBJECTIVES:
To study the clinical efficacy of antibiotics in children with chronic wet cough (CWC).
To study if duration of treatment with antibiotics in children with CWC has impact on efficacy or time to relapse of symptoms.
OVERALL SECONDARY OBJECTIVE:
-To study respiratory pathogens and the diversity/composition of airway and gut microbiome in children with CWC compared to healthy controls, and changes in pathogens/microbiome after treatment with antibiotics.
OVERALL TERTIARY OBJECTIVE:
-To study inflammatory markers in children with CWC and the impact of treatment with antibiotics. Furthermore, identify children with CWC who have primary immunodeficiency (PID) based on functional laboratory markers and genetic markers of PID.
The study will include two different interventions:
INTERVENTION 1:
Participants will be randomly assigned to 14 days antibiotics or placebo
INTERVENTION 2:
Participants will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup

开始日期2023-08-16

申办/合作机构

Helse Stavanger HF

[+5]

ISRCTN79883982 / RecruitingN/A

A multi-centre, prospective, cross-sectional cohort study comparing the microbiology yields of cough swab and induced sputum samples with that of bronchoalveolar lavage samples obtained during flexible bronchoscopy, in children with protracted bacterial bronchitis

开始日期2021-10-29

申办/合作机构

University Hospitals of North Midlands NHS Trust

ACTRN12622000430730 / RecruitingN/A

Change in health outcomes for Aboriginal children with chronic wet cough rationale and study protocol for a multi-centre implementation science study

开始日期2021-05-10

申办/合作机构

Child & Adolescent Health Service

100 项与细菌性下呼吸道感染相关的临床结果

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100 项与细菌性下呼吸道感染相关的转化医学

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0 项与细菌性下呼吸道感染相关的专利（医药）

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434

项与细菌性下呼吸道感染相关的文献（医药）

2024-10-03·Microbiology Spectrum

Protein and transcriptional biomarker profiling may inform treatment strategies in lower respiratory tract infections by indicating bacterial–viral differentiation

Article

作者: Serigstad, Sondre ; Ulvestad, Elling ; Grewal, Harleen M. S. ; Saghaug, Christina Skår ; Markussen, Dagfinn Lunde ; Jenum, Synne ; Sivakumaran, Dhanasekaran ; Srivastava, Aashish ; Knoop, Siri Tandberg

ABSTRACT Lower respiratory tract infections (LRTIs) remain a significant global cause of infectious disease-related mortality. Accurate discrimination between acute bacterial and viral LRTIs is crucial for optimal patient care, prevention of unnecessary antibiotic prescriptions, and resource allocation. Plasma samples from LRTI patients with bacterial ( n = 36), viral ( n = 27; excluding SARS-CoV-2), SARS-CoV-2 ( n = 22), and mixed bacterial–viral ( n = 38) etiology were analyzed for protein profiling. Whole-blood RNA samples from a subset of patients (bacterial, n = 8; viral, n = 8; and SARS-CoV-2, n = 8) were analyzed for transcriptional profiling. Lasso regression modeling identified a seven-protein signature (CRP, IL4, IL9, IP10, MIP1α, MIP1β, and TNFα) that discriminated between patients with bacterial ( n = 36) vs viral ( n = 27) infections with an area under the curve (AUC) of 0.98. When comparing patients with bacterial and mixed bacterial–viral infections (antibiotics clinically justified; n = 74) vs patients with viral and SARS-CoV-2 infections (antibiotics clinically not justified; n = 49), a 10-protein signature (CRP, bFGF, eotaxin, IFNγ, IL1β, IL7, IP10, MIP1α, MIP1β, and TNFα) with an AUC of 0.94 was identified. The transcriptional profiling analysis identified 232 differentially expressed genes distinguishing bacterial ( n = 8) from viral and SARS-CoV-2 ( n = 16) etiology. Protein–protein interaction enrichment analysis identified 20 genes that could be useful in the differentiation between bacterial and viral infections. Finally, we examined the performance of selected published gene signatures for bacterial–viral differentiation in our gene set, yielding promising results. Further validation of both protein and gene signatures in diverse clinical settings is warranted to establish their potential to guide the treatment of acute LRTIs. IMPORTANCEAccurate differentiation between bacterial and viral lower respiratory tract infections (LRTIs) is vital for effective patient care and resource allocation. This study investigated specific protein signatures and gene expression patterns in plasma and blood samples from LRTI patients that distinguished bacterial and viral infections. The identified signatures can inform the design of point-of-care tests that can aid healthcare providers in making informed decisions about antibiotic prescriptions in order to reduce unnecessary use, thereby contributing to reduced side effects and antibiotic resistance. Furthermore, the potential for faster and more accurate diagnoses for improved patient management in acute LRTIs is compelling.

2024-09-01·Annals of Allergy, Asthma & Immunology

A penicillin allergy stewardship team to address unconfirmed pediatric penicillin allergies in Houston, Texas

Article

作者: Buheis, Maria ; Anvari, Sara ; Lucas, Beverly ; Hearrell, Melissa ; Taylor, Margaret G ; Kok, Melissa ; Miller, Jennifer

BACKGROUNDPenicillin (PCN) allergy labels are the most common drug allergy label and limit use of first-line antibiotics for many pediatric bacterial infections. Improving access to PCN allergy evaluations is a priority for allergy and immunology (A&I) and infectious diseases (ID) programs.OBJECTIVETo increase the number of completed PCN allergy evaluations from 6 to 24 per month from January 2022 to December 2023.METHODSA collaborative PCN allergy stewardship team was established in the A&I and ID divisions at Texas Children's Hospital. Telemedicine evaluations and, when clinically indicated, in-person PCN allergy evaluations were conducted from January 2022 to December 2023. Plan-do-study-act cycles were conducted to increase awareness about the clinics. The primary outcome measure was the average number of monthly completed PCN allergy evaluations.RESULTSThe average number of completed PCN allergy evaluations increased from 6 to 19 per month. Children were seen rapidly in the ID telemedicine clinic (20 vs 62 days, P < .001), and 428 of 627 (68%) children who required in-person challenge were scheduled for their in-person evaluation. Among the 211 children delabeled, 71 (33.6%) were subsequently diagnosed with a bacterial infection requiring PCN during the study period.CONCLUSIONA collaborative PCN allergy stewardship team consisting of ID and A&I specialists increased the number of completed PCN allergy evaluations 3-fold. ID telemedicine services allowed prompt access to care, and most children were delabeled and subsequently able to receive PCN antibiotics for bacterial respiratory tract infections. Future work should explore ways to minimize barriers to PCN allergy evaluations and further expand testing services in other settings.

2024-08-01·American family physician

Chronic Cough: Evaluation and Management.

Article

作者: Nayak, Ravi ; Sonoda, Kento

Chronic cough is a cough lasting longer than 8 weeks in adults and 4 weeks in children. In the United States, more than 12.3 million individuals are estimated to have chronic cough. The most common causes of chronic cough in adults are upper airway cough syndrome, asthma, nonasthmatic eosinophilic bronchitis, gastroesophageal reflux disease, and laryngopharyngeal reflux. The initial assessment of chronic cough should include cost-effective diagnostic tests, such as chest radiography and spirometry, and empiric and targeted treatment for the most common etiologies. An assessment of medications (e.g., angiotensin-converting enzyme inhibitors), environment, occupation, and potential chemical triggers should be conducted. For chronic refractory cough, physiotherapy and speech and language therapy combined with a trial of gabapentin or amitriptyline can be considered. When initial test findings are unremarkable, further diagnostic tests, such as bronchoscopy and nasendoscopy, are often warranted through referral to a pulmonologist and otolaryngologist. Common etiologies in children include protracted bacterial bronchitis, asthma, bronchiectasis, upper airway cough syndrome, and gastroesophageal reflux disease. Because of the high likelihood of spontaneous resolution, children with a dry cough without wheezing or exertional dyspnea may be observed for 2 weeks.