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Not yet recruitingNCT07647835PnemoniaUpdated Jun 15, 2026

3 vs. 5 Days of Amoxicillin for Childhood Pneumonia: An RCT

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

Phase
Early Phase 1
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
3 Months to 5 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Community Acquired Pneumonia
  • Childhood Pneumonia

Keywords

  • Amoxcillin in childhood pneumonia
  • community acquired pneumonia
03

In context

Community-Acquired Pneumonia

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 →

Lead sponsor

Khyber Teaching Hospital is the lead sponsor of 29 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age; ≥ 3 months to 5 years
  • Fever; recorded temperature of ≥100.4 f or guardian reported fever within 2 days
  • Cough; observed or reported within 3 days
  • Tachypnea;
  • 3 months to 1 years ≥ 50 breaths per minute
  • 1 years to 5 years ≥ 40 breaths per minute
  • C- reactive protein ≥ 40
  • White blood cells ≥ 12200
  • Chest X-ray;
  • Presence of a dense opacity occupying a portion or whole of lobe with or without air Broncho grams.

Exclusion criteria

Exclusion criteria:

  • Patient who is Lethargic and unable to tolerate orally.
  • Capillary refill greater than 2 second
  • Chronic lung disease
  • Congenital heart disease or sickle cell anemia patient
  • patient
  • malnourished
  • Known or suspected tuberculosis patient
  • Patient has used prior antibiotic within 2 days
  • Allergic to penicillin or amoxicillin
  • C-reactive protein greater than 72
  • White blood cells greater than 25000
  • Chest x rays show linear or patchy or peri bronchial opacity
  • Presence of pleural effusions
  • Empyema, lung abscess, necrotizing pneumonia or pneumatocele
  • Other alternative diagnosis like wheezing syndrome (Bilateral wheezing on auscultation)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

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.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
250 participants (estimated)

Study arms

  • Active comparator
    - Group B (5-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 5 days.

    \- Group B (5-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 5 days.

    Drug: Amoxicillin

  • Experimental
    Group A (3-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 3 days

    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

Interventions

  • Giving drug for 3 days instead of 5 days

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2026; primary completion for Jun 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2026
First posted
Jun 15, 2026
StartEst.
Jun 1, 2026
Primary completionEst.
Jun 1, 2027
CompletionEst.
Jun 1, 2027
Last update
Jun 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07647835
Lead sponsor
Khyber Teaching Hospital
Responsible party
Zia Muhammad (Associate Professor and supervisor Department Of Child Health Khyber Teaching Hospital Peshawar, Khyber Teaching Hospital) — Principal investigator
First posted
Jun 15, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Jun 15, 2026

Study contacts

Zia Muhammad, MBBS FCPS CHPE CHR PGPN
Contact
drziamuhammad@gmail.com
+923315500086

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Amoxicillin

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