An Early Phase 1 interventional study of Amoxicillin in Community Acquired Pneumonia and Childhood Pneumonia, sponsored by Khyber Teaching Hospital. Not yet recruiting at 1 site in Pakistan. Open to participants aged 3 Months to 5 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Khyber Teaching Hospital · Early Phase 1, Interventional, and Treatment
Pneumonia is the most common infection in children and leading to most common cause of mortality and morbidity in in children globally. Bacterial cause is mostly streptococcus pneumonia in children of 3 months to 5 years of age. Traditionally 7-10 antibiotic is used for uncomplicated community acquired pneumonia. World health organization (WHO) recommends 5 days of antibiotic for non-severe pneumonia with oral amoxicillin while National institute for health and care excellence (NICE) guidelines 2025 recommends 3-days course of amoxicillin in uncomplicated community acquired pneumonia.1,2 Most studies show Short course antibiotic is as effective as long course of antibiotic with fewer side effect. The Khyber Pakhtunkhwa province faces particular challenges due to limited healthcare access, malnutrition, and suboptimal vaccination coverage which leads to major burden of pneumonia in less than 5 years' children.7 There is need of local data about effectiveness of short course antibiotic in uncomplicated community acquired pneumonia. 3-day oral amoxicillin has better compliance and less side effect of medicine. Short course of oral amoxicillin is cost effective as pneumonia is more common in low socioeconomic population and 3-day course antibiotic is more economical and has better compliance. Long course of antibiotic leads to antibiotic resistance and adverse effects like diarrhea and other gastrointestinal symptoms.
Pneumonia is the most common infection in children and leading to most common cause of mortality and morbidity in in children globally. Bacterial cause is mostly streptococcus pneumonia in children of 3 months to 5 years of age. Traditionally 7-10 antibiotic is used for uncomplicated community acquired pneumonia. World health organization (WHO) recommends 5 days of antibiotic for non-severe pneumonia with oral amoxicillin while National institute for health and care excellence (NICE) guidelines 2025 recommends 3-days course of amoxicillin in uncomplicated community acquired pneumonia.1,2 Most studies show Short course antibiotic is as effective as long course of antibiotic with fewer side effect. The SAFARI trial demonstrated non-inferiority of 5-day versus 10-day amoxicillin therapy in children with Community acquired pneumonia, with comparable clinical cure rates and reduced antibiotic exposure.3 Similarly, a systematic review and meta-analysis by Pernica et al. found that short-course antibiotic therapy (≤5 days) was associated with similar clinical success rates compared to longer courses in pediatric respiratory infections.4 Mortality due to childhood pneumonia is strongly linked to poverty-related factors such as undernutrition, lack of safe drinking water and sanitation, indoor and outdoor air pollution as well as inadequate access to health care.
Pneumonia kills more children than any other infectious disease, claiming the lives of over 700,000 children under 5 every year, or around 2,000 every day. This includes around 190,000 newborns. Almost all of these deaths are preventable. Globally, there are over 1,400 cases of pneumonia per 100,000 children, or 1 case per 71 children every year, with the greatest incidence occurring in South Asia (2,500 cases per 100,000 children) and West and Central Africa (1,620 cases per 100,000 children).5 No disease kills more children aged less than five years than pneumonia, not least in Pakistan where one-fifth of the population is in this age group. The annual incidence of ARI (acute respiratory infection) in Pakistani children aged less than five years is 4% in the community a group constituting roughly 22% of the country's population of 160 million. Taking this 4% figure, we can calculate that there are 15 million episodes of ARI every year among under-fives.6 The Khyber Pakhtunkhwa province faces particular challenges due to limited healthcare access, malnutrition, and suboptimal vaccination coverage which leads to major burden of pneumonia in less than 5 years' children.7 There is need of local data about effectiveness of short course antibiotic in uncomplicated community acquired pneumonia. 3-day oral amoxicillin has better compliance and less side effect of medicine. Short course of oral amoxicillin is cost effective as pneumonia is more common in low socioeconomic population and 3-day course antibiotic is more economical and has better compliance. Long course of antibiotic leads to antibiotic resistance and adverse effects like diarrhea and other gastrointestinal symptoms.
324 studies on the registry are indexed under Community-Acquired Pneumonia; 77 are open to participants now.
This study's planned enrollment of 250 is close to the median of 250 across 195 interventional studies indexed under Community-Acquired Pneumonia.
Browse Community-Acquired Pneumonia studies →Khyber Teaching Hospital is the lead sponsor of 29 studies on the registry; 19 are open to participants now.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
\- Group B (5-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 5 days.
Drug: Amoxicillin
Group A (3-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 3 days, followed by matched placebo for days 4-5
Drug: Amoxicillin
Giving drug for 3 days instead of 5 days
Number of Participants with Clinical Cure at Day 14
Participants who * are afebrile for at least 48 hours (temperature \<38°C) * have normal respiratory rate for age * have no chest indrawing or nasal flaring * return to normal feeding and activity level * do not require additional antibiotics
Time frame: 14 days
Number of Participants withTreatment Failure:
Participants who * have persistence of fever or tachypnea at Day 5 * develop chest indrawing, hypoxemia (SpO2 \<92%), or danger signs (drowsiness, i-nability to drink, convulsions) * need hospitalization or intravenous antibiotics * require second-line antibiotic therapy * expire
Time frame: 5 days
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Jun 2027, 12 months later.
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Studies of the drug tested here: Amoxicillin
Community-Acquired Pneumonia →
Khyber Teaching Hospital