Community Acquired PneumoniaEarly Phase 1PnemoniaNCT07647835
3 vs. 5 Days of Amoxicillin for Childhood Pneumonia: An RCT
A Early Phase 1 study testing Amoxicillin in people with Community Acquired Pneumonia and Childhood Pneumonia, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Community Acquired Pneumonia, Childhood Pneumonia
- What is being tested?
- Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
- Immunocompromised patient
- malnourished
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Khyber Teaching Hospital
Peshawar, Khyber Pakhtunkhwa, 25000
Zia Muhammad, 03315500086, drziamuhammad@gmail.com
About this study
Official title: Comparison 0f 03days Vs 05days Amoxicillin In Uncomplicated Community Acquired Pneumonia In Children. A Randomized Controlled Trial
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.
- Conditions
- Community Acquired Pneumonia, Childhood Pneumonia
- Being tested
- Amoxicillin
- Keywords
- Amoxcillin in childhood pneumonia, community acquired pneumonia
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Giving drug for 3 days instead of 5 days
| Study group | Role | What they receive |
|---|---|---|
| - Group B (5-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 5 days. | Active comparator | - Group B (5-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 5 days. Receives: Drug: Amoxicillin |
| Group A (3-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 3 days | Experimental | 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 Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PROBE (Prospective randomized open label blinded endpoint) single-blind, randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zia Muhammad, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647835
- Sponsor's protocol ID
- 318/IREB/KTH
- Acronym
- Pnemonia
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison 0f 03days Vs 05days Amoxicillin In Uncomplicated Community Acquired Pneumonia In Children. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07647835
- Acronym / sponsor ID
- Pnemonia / 318/IREB/KTH
- Conditions
- Community Acquired Pneumonia, Childhood Pneumonia
- Keywords
- Amoxcillin in childhood pneumonia, community acquired pneumonia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- PROBE (Prospective randomized open label blinded endpoint) single-blind, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| - Group B (5-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 5 days. | Active comparator | Drug: Amoxicillin- Group B (5-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 5 days. |
| Group A (3-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 3 days | Experimental | Drug: AmoxicillinGroup A (3-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 3 days, followed by matched placebo for days 4-5 |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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
- Immunocompromised patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmoxicillinGiving drug for 3 days instead of 5 days | Drug | - Group B (5-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 5 days., Group A (3-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 3 days |
Primary outcome
Number of Participants with Clinical Cure at Day 14
Time frame: 14 days
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
Number of Participants withTreatment Failure:
Time frame: 5 days
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Local Antibiotic Delivery for Community Acquired Pneumonia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Amoxicillin in people with Community Acquired Pneumonia and Childhood Pneumonia, run by Khyber Teaching Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zia Muhammad, MBBS FCPS CHPE CHR PGPN (+923315500086, drziamuhammad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Clinical Cure at Day 14 (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.