Fast Breathing in Young InfantsPhase 4MAT-YINCT01533818
Community Based Management of Fast Breathing in Infants Aged < 60 Days in Low-income Settlements of Karachi
A Phase 4 study testing Amoxicillin and Sugar Syrup in people with Fast Breathing in Young Infants, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The aim of the study is to determine optimal management of isolated fast breathing in young infants in a trial design conducted in primary care settings. The investigators hypothesized that proportion of infants who fail therapy will be 4% in each group. Read more about this study
- Who is it for?
- Ages Up to 59 days
- Conditions the study is for
- Fast Breathing in Young Infants
- What is being tested?
- Amoxicillin and Sugar Syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 963 participants
- Where
- 1 sitePakistan
- Study dates
- May 2012to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Up to 59 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Young infant (0-59 days of age)
- Fast breathing i.e., respiratory rate ≥60 breaths/min
- O2 Saturation ≥90%
- Resident of catchment area (to ensure complaint and follow up)
- Refused hospitalization and investigations
- Informed consent is provided by a parent (or legal guardian).
Who cannot join
- Preterm infants (born <37 weeks)
- Presence of audible murmur
- Any concurrent signs of severe infection:
- not feeding well
- movement only when stimulated
- severe chest in-drawing
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- axillary temperature ≥38.0oC or ≤35.5oC
- Any sign of being critically ill (Cyanosis, bulging fontanel, unable to feed, unable to cry, apnoea, convulsions, unconscious, persistent vomiting)
- Weight <1800gm at the time of presentation
- Major congenital malformations or suspected chromosomal abnormalities
- Hospitalization for illness in the last two weeks
- Previous inclusion in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Based Management of Fast Breathing in Infants Aged < 60 Days: A Double-Blind, Randomized Placebo-Controlled Trial in Low-income Settlements of Karachi
The aim of the study is to determine optimal management of isolated fast breathing in young infants in a trial design conducted in primary care settings.
The investigators hypothesized that proportion of infants who fail therapy will be 4% in each group. A 6% or less difference in failure rate will be considered equivalent.
Read the detailed description
The management of isolated fast breathing is therefore unknown and our experience suggests that these infants could perhaps be managed without antibiotics. Widespread application of the WHO clinical algorithm could therefore result in the referral of as many as 13.7% (135.7 per 1000 live births) of all infants for isolated fast breathing, the vast majority of these unnecessarily, and exposing infants to a high risk of nosocomial sepsis and hospital mortality in addition to over-burdening health resources.
- Conditions
- Fast Breathing in Young Infants
- Being tested
- Amoxicillin, Sugar Syrup
- Keywords
- Fast breathing, Young infants, Management, Amoxicillin, Placebo
- Medical subject headings
- Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
80-100 mg/kg/day in 2 divided doses for 7 days
For convenience dose divided into six weight bands Table 2: Dose of amoxicillin Weight band Amount per dose Daily dose Lower Limit (mg or units /kg/d) Upper Limit (mg or units /kg/d) Amoxicillin - desired range 75-100 mg/kg/day (25mg/ml (125mg/5ml); twice daily orally)* 1.8-1.9 kg 3.0 ml 150 mg 75.4 100.0 2.0-2.4 kg 4.0 ml 200 mg 80.3 100.0 2.5-2.9 kg 5.0 ml 250 mg 83.6 100.0 3.0-3.9 kg 6.0 ml 300 mg 75.2 100.0 4.0-4.9 kg 8.0 ml 400 mg 80.2 100.0 5.0-5.9 kg 10.0 ml 500 mg 83.5 100.0
Sugar SyrupDrug
It will be given 2 times/day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin | Active comparator | This is an active intervention Receives: Drug: Amoxicillin |
| Sugar Syrup | Placebo comparator | Not described Receives: Drug: Sugar Syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
- O2 sat <90% on Day 2 or any time until Day 7.
- Clinical deterioration: emergence of any sign of being critically ill or severe infection at any time after randomization (as defined in exclusion criteria)
- Development of serious adverse effect of the study antibiotics (death, organ failure, anaphylactic reaction, severe diarrhoea, disseminated and severe rash).
- Hospitalization any time after admission in the study.
- Death anytime within day 1-7 of enrolment
Measured: Day 8 of enrollemnt
Secondary outcomes (2)
Compliance to treatment
To label as per protocol infant should receive 100% (4 doses) of doses in first 2 days followed by 70% (7 doses) of doses from day 3 to day 8.
Measured: 80% of total dosage
Proportion of infants relapse
Measured: No treatment failure by day 8 and signs of sepsis or fast breathing between day 8-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: The study was stopped by DSMB based on high treatment failure rate in placebo compared to active drug.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fast Breathing in Young InfantsStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 963 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyam Sunder Tikmani, Aga Khan University
- Investigators
- Shiyam Sunder P Tikmani, MBBS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533818
- Sponsor's protocol ID
- 1979-CHS-ERC-11
- Acronym
- MAT-YI
- Status last verified
- Jun 2014
- First submitted
- 13 Feb 2012
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tikmani SS, Muhammad AA, Shafiq Y, Shah S, Kumar N, Ahmed I, Azam I, Pasha O, Zaidi AK. Ambulatory Treatment of Fast Breathing in Young Infants Aged <60 Days: A Double-Blind, Randomized, Placebo-Controlled Equivalence Trial in Low-Income Settlements of Karachi. Clin Infect Dis. 2017 Jan 15;64(2):184-189. doi: 10.1093/cid/ciw690. Epub 2016 Oct 19.
PubMed 27941119
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Based Management of Fast Breathing in Infants Aged < 60 Days: A Double-Blind, Randomized Placebo-Controlled Trial in Low-income Settlements of Karachi
- ClinicalTrials.gov ID
- NCT01533818
- Acronym / sponsor ID
- MAT-YI / 1979-CHS-ERC-11
- Conditions
- Fast Breathing in Young Infants
- Keywords
- Fast breathing, Young infants, Management, Amoxicillin, Placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped by DSMB based on high treatment failure rate in placebo compared to active drug.
- Enrolment
- 963 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Feb 2012 (estimated)
- 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.
The aim of the study is to determine optimal management of isolated fast breathing in young infants in a trial design conducted in primary care settings.
The investigators hypothesized that proportion of infants who fail therapy will be 4% in each group. A 6% or less difference in failure rate will be considered equivalent.
Detailed description
The management of isolated fast breathing is therefore unknown and our experience suggests that these infants could perhaps be managed without antibiotics. Widespread application of the WHO clinical algorithm could therefore result in the referral of as many as 13.7% (135.7 per 1000 live births) of all infants for isolated fast breathing, the vast majority of these unnecessarily, and exposing infants to a high risk of nosocomial sepsis and hospital mortality in addition to over-burdening health resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin | Active comparator | Drug: AmoxicillinThis is an active intervention |
| Sugar Syrup | Placebo comparator | Drug: Sugar Syrup |
Who may qualify
- Ages
- Up to 59 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Young infant (0-59 days of age)
- Fast breathing i.e., respiratory rate ≥60 breaths/min
- O2 Saturation ≥90%
- Resident of catchment area (to ensure complaint and follow up)
- Refused hospitalization and investigations
Key exclusion criteria (12 listed)
- Preterm infants (born <37 weeks)
- Presence of audible murmur
- Any concurrent signs of severe infection:
- not feeding well
- movement only when stimulated
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 |
|---|---|---|
| Amoxicillin80-100 mg/kg/day in 2 divided doses for 7 days For convenience dose divided into six weight bands Table 2: Dose of amoxicillin Weight band Amount per dose Daily dose Lower Limit (mg or units /kg/d) Upper Limit (mg or units /kg/d) Amoxicillin - desired range 75-100 mg/kg/day (25mg/ml (125mg/5ml); twice daily orally)* 1.8-1.9 kg 3.0 ml 150 mg 75.4 100.0 2.0-2.4 kg 4.0 ml 200 mg 80.3 100.0 2.5-2.9 kg 5.0 ml 250 mg 83.6 100.0 3.0-3.9 kg 6.0 ml 300 mg 75.2 100.0 4.0-4.9 kg 8.0 ml 400 mg 80.2 100.0 5.0-5.9 kg 10.0 ml 500 mg 83.5 100.0 | Drug | Amoxicillin |
| Sugar SyrupIt will be given 2 times/day for 7 days | Drug | Sugar Syrup |
Primary outcome
Treatment failure
Time frame: Day 8 of enrollemnt
1. O2 sat <90% on Day 2 or any time until Day 7. 2. Clinical deterioration: emergence of any sign of being critically ill or severe infection at any time after randomization (as defined in exclusion criteria) 3. Development of serious adverse effect of the study antibiotics (death, organ failure, anaphylactic reaction, severe diarrhoea, disseminated and severe rash). 4. Hospitalization any time after admission in the study. 5. Death anytime within day 1-7 of enrolment
2 secondary outcomes
Compliance to treatment
Time frame: 80% of total dosage
Proportion of infants relapse
Time frame: No treatment failure by day 8 and signs of sepsis or fast breathing between day 8-14
Results and safety
The study was stopped early (reason given: The study was stopped by DSMB based on high treatment failure rate in placebo compared to active drug.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
- Derived from this study: PubMed 27941119Tikmani SS, Muhammad AA, Shafiq Y, Shah S, Kumar N, Ahmed I, Azam I, Pasha O, Zaidi AK. Ambulatory Treatment of Fast Breathing in Young Infants Aged <60 Days: A Double-Blind, Randomized, Placebo-Controlled Equivalence Trial in Low-Income Settlements of Karachi. Clin Infect Dis. 2017 Jan 15;64(2):184-189. doi: 10.1093/cid/ciw690. Epub 2016 Oct 19.
- Related InfoLink provided by the sponsor.
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. This study is not recruiting at the moment.
Shiyam Sunder P Tikmani, MBBS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin and Sugar Syrup in people with Fast Breathing in Young Infants, run by Aga Khan University 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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 3 Jun 2014. 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. Some participants in this study may receive a placebo. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was stopped by DSMB based on high treatment failure rate in placebo compared to active drug.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: Day 8 of enrollemnt). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01533818, which also lists 1 linked publication.
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 3 Jun 2014; AzTrials last refreshed its copy on 7 Nov 2026.