Efficacy of Two Doses of Parenteral Amoxicillin Plus Single Dose Gentamicin Compared to Four Doses of Parenteral Ampicillin Plus Single Dose Gentamicin in Managing Children Hospitalized With WHO Classified Severe Pneumonia: a RCT

Severe pneumonia is a serious infection in children which requires timely intervention. Management of severe pneumonia is done by appropriate antibiotics and supportive care. WHO recommendation is to use injection ampicillin four times a day for 3-5 days and injection gentamicin once a day for 3-5 days in children with severe pneumonia. In the study, the investigators want to compare the response of injection ampicillin with another similar and equally effective antibiotic (amoxicillin). The reason for choosing amoxicillin is that the dose is two times a day and it is cost-effective and reduces chances of nosocomial infection. The response of the drugs will be compared by the time difference of clinical improvement of the patients or time difference of disappearance of the sign and symptoms on admission. The investigators are interested to compare the recovery time from the illness as well as treatment failure in both groups. In that way, the investigators will be able to develop a better treatment for pneumonia in children in low-cost settings.

The study will be an open-label, randomized, controlled intervention in children between two months to 59 months admitted to Dhaka Hospital of icddr,b. Investigators will use sealed envelopes to randomly assign the children to either treatment arm. In the first arm children will receive 2 daily doses of parenteral Amoxicillin and a single daily dose of parenteral Gentamicin; and in 2nd arm, children will receive 4 daily doses of parenteral Ampicillin and a single daily dose of parenteral Gentamicin. After 72 hours of treatment, injection Amoxicillin and injection Ampicillin will be replaced with oral Amoxicillin but injection gentamicin will be continued for a total of 5 days in one daily dose. During this time participants will be suggested to discharge from the hospital and attain to the Ambulatory care unit for getting a once-daily dose of injection of Gentamicin. Both the treatment arm will continue for 5 days.

During the study period, participants in both study arms will also receive standardized hospital management for other co-morbidities-such as diarrhea, malnutrition, and any other complications. Hypoxia will be managed by B-CPAP through a nasal cannula.

Any participants will be declared "Treatment failure" who show the persistence of danger signs after 48 hours or develop new danger signs within 24 hours of initiation of antibiotic treatment. If a participant needs mechanical ventilation, dies at any time during a hospital stay, or left the hospital against medical advice will be also declared as a treatment failure.

Participants from either study group who develops the features of "treatment failure" should be rescued with the second-line antibiotic regimen, which is injection ceftriaxone and injection levofloxacin.