Clinical trial to evaluate the effect of Leucomycin A3 (Josamycin) in severe and very severe community-acquired pneumonia in Filipino children 2-5 years old ( a pilot study).

Clinical trial to evaluate the effect of Leucomycin A3 (Josamycin) in severe and very severe community-acquired pneumonia in Filipino children 2-5 years old ( a pilot study). - Study on the use of Leucomycin A3 (Josamycin) in severe and very severe community-acquired pneumonia of children

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026440

Enrollment

100

Registered

2017-03-08

Start date

2017-03-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe and very severe community-acquired pneumonia

Interventions

Josamycine 30 mg/kg BW/days for maximum 14 days. 1. Use dry syrup of Josamycin 10%. (Josamy DS : Josamycin 10% dry syrup) 2. 10mg/kg BW x 3 times/day p.o. administration 3. Will be able to con

s family member let the patient take it. If it is difficult to take as it is, dissolve in a small amount of water (less than 5 ml) to give.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Severe and very severe community-acquired pneumonia (based on WHO definition) Patients who filfull all of the followings(1-6:should be included,7:if possible) 1.The patients seen at the UP-PGH. (Out-patient and Hospitalized patients) 2.Age:2-5 years old 3.Chest X ray abnormal shadow(consolidation, ground-glass opacity, or nodular shadow) 4.High fever(over 38 degree) on admission 5.Patients provide written informed consent prior to initiation of any study procedures. 6.Patients who or Legally Acceptable Representative (LAR) is able to understand and comply with planned study procedures. 7.PaO2/FiO2 ratio (P/F ratio) is lower than 300 mmHg in arterial blood gas analysis.

Exclusion criteria

Exclusion criteria: Patients who fulfill any of the followings are excluded 1.Patients with severe renal dysfunction (creatinine clearance is lower than 10mL/min) 2. Patients whom the treating doctor deems, for any reason, to be ineligible. 3. Patients with underlying heart conditions i.e. congenital heart disease. 4. The patient's LAR wants to stop the study,even if after the study have started.

Design outcomes

Primary

Measure	Time frame
Mortality Duration of response to therapy Duration of signs and symptoms of the disease	—

Countries

Japan,Asia(except Japan)

Contacts

Public ContactShoji Kawachi

Teikyo University the Asia International Institute of Infectious Disease Control (ADC)

office-adc@med.teikyo-u.ac.jp03-3964-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026