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Table 4 Criteria and procedures for discontinuation or modification of the allocated investigational medicinal product. AE adverse event, FiO2 fraction of inspired oxygen, IMP investigational medicinal product, ICU intensive care unit

From: A randomized controlled non-inferiority trial of placebo versus macrolide antibiotics for Mycoplasma pneumoniae infection in children with community-acquired pneumonia: trial protocol for the MYTHIC Study

Discontinuation criteria

Modification criteria

• Any change in the patient’s condition that justifies the discontinuation of the IMP (e.g., need for ICU transfer).

• Unacceptable toxicity or AE (according to the prescribing information).

• Use of a medication with a known major drug interaction with azithromycin.

• Withdrawal of informed consent for IMP by patient/parent.

Ambulatory patients:

• Need for hospital admission.

Hospitalized patients:

• Failure to maintain oxygen saturation ≥90% with FiO2 100%.

• Oxygen saturation <90% for >48 h.

• Clinical features of severe respiratory distress/exhaustion and/or shock/sepsis.

Procedures:

Procedures:

• Stop IMP.

• Treatment modification with antibiotics against atypical pathogensa; and/or

• Switch to standard of care.b

  1. aTreatment alternatives to the IMP (azithromycin as active drug) against atypical pathogens (e.g., M. pneumoniae, Chlamydia pneumoniae) must be discussed between the local investigators and the trial management team. These include clarithromycin (as another macrolide) or doxycycline in children >7 years of age (also as treatment option for infections with macrolide-resistant M. pneumoniae (MRMP)) [6]. In case of clinical suspicion of MRMP infection (e.g., worsening and/or non-responding symptoms), testing and (modifying) treatment for MRMP should be initiated irrespective of the study. The trial management team will also support the local team at the participating centers in managing infections with (possible) MRMP
  2. bDecision about switch to standard of care (defined as treatment-as-usual, usual care, or routine care) will be made by the local team. The IMP should be continued for the total 5-day treatment duration whenever possible
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ISSN: 1745-6215