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ARTIC PC - Antibiotics for lower Respiratory Tract Infection in Children presenting in Primary Care

The inclusion and exclusion criteria are listed here

Inclusion criteria are Children between 6 months and 12 years old presenting with an acute uncomplicated lower respiratory infection (LRTI), defined as an acute cough, as the predominant symptom, judged by the GP or Nurse Practitioner to be infective in origin, lasting <21 days, and with other symptoms or signs localising to the lower tract (sputum) and the Parent/guardian willing and able to be contacted for follow up and complete a symptom diary for up to 28 days. 

We are assuming lower tract symptoms/signs are also ’rattly chest’/coarse rhonchi; breathless; pain.

Exclusion criteria for the observational element are;

• Non-infective (e.g. reflux, Pulmonary Embolism (PE)) or croup (where viral aetiology is very likely). This includes where exacerbations of asthma are the clear and prominent cause of the cough/bronchoconstriction.

• Those with clinically suspected pneumonia or very unwell and/or unwilling to be randomised will be invited to participate in an observational study collecting the same data.

• Severe tachypnoea as judged by the recruiting clinician.

• Immune-compromised.(including suspected Bordetella Pertussis)

• Antibiotic use in previous 30 days.

Children with asthma whose presentation is felt to be due to a non-infective asthma exacerbation and in whom antibiotics are not being considered eligible, nor children without a previous diagnosis of asthma in whom the presentation is suggestive of asthma rather than an infection (as per national asthma guidelines, e.g a less acute history, predominant wheeze, breathlessness, reduced peak expiratory flow rate, asthma risk factors).

In addition exclusion criteria for the trial are;

• Children with hypersensitivity to any of the penicillins should also be excluded or to any of the excipients.

• History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).

• History of jaundice/hepatic impairment due to amoxicillin.

• Children who are on concomitant medication which, based on the clinical judgment of the clinician, may lead to clinically significant interaction with amoxicillin.

• Children with known severe renal failure, hepatic failure, infectious mononucleosis (active or within last two months), or phenylketonuria.

• Children currently taking any medications known to interact with amoxicillin (e.g. probenecid, sulfinpyrazone, methotrexate, mycophenolate, oral anticoagulants) or increase the risk of adverse reactions (e.g. allopurinol).

• If a sibling living in the same household is already enrolled on the trial taking project medication.

• Suspected pneumonia based on clinical examination (oxygen saturation below 92% or focal rales) or being very severely ill as judged by the GP.

• Children previously entered into the ARTIC PC trial.

• Children who have been involved in another medicinal trial within the last 90 days.

• The criteria for referral to hospital using the NICE Feverish Children Clinical Guideline or NICE guideline on Sepsis in Children and Adults.

• Individuals with very severe, oral steroid-dependent asthma who may be at greater risk of serious infection.

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