Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-03 @ 12:35 AM
Study NCT ID:
NCT01533818
Status:
TERMINATED
Last Update Posted:
2014-06-03
First Post:
2012-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community Based Management of Fast Breathing in Infants Aged < 60 Days in Low-income Settlements of Karachi
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006985', 'term': 'Hyperventilation'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D066248', 'term': 'High Fructose Corn Syrup'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000073417', 'term': 'Dietary Sugars'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D064427', 'term': 'Nutritive Sweeteners'}, {'id': 'D013549', 'term': 'Sweetening Agents'}, {'id': 'D005421', 'term': 'Flavoring Agents'}, {'id': 'D005503', 'term': 'Food Additives'}, {'id': 'D000074385', 'term': 'Food Ingredients'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 963}}, 'statusModule': {'whyStopped': 'The study was stopped by DSMB based on high treatment failure rate in placebo compared to active drug.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-02', 'studyFirstSubmitDate': '2012-02-13', 'studyFirstSubmitQcDate': '2012-02-14', 'lastUpdatePostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment failure', 'timeFrame': 'Day 8 of enrollemnt', 'description': '1. O2 sat \\<90% on Day 2 or any time until Day 7.\n2. Clinical deterioration: emergence of any sign of being critically ill or severe infection at any time after randomization (as defined in exclusion criteria)\n3. Development of serious adverse effect of the study antibiotics (death, organ failure, anaphylactic reaction, severe diarrhoea, disseminated and severe rash).\n4. Hospitalization any time after admission in the study.\n5. Death anytime within day 1-7 of enrolment'}], 'secondaryOutcomes': [{'measure': 'Compliance to treatment', 'timeFrame': '80% of total dosage', 'description': '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.'}, {'measure': 'Proportion of infants relapse', 'timeFrame': 'No treatment failure by day 8 and signs of sepsis or fast breathing between day 8-14'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fast breathing', 'Young infants', 'Management', 'Amoxicillin', 'Placebo'], 'conditions': ['Fast Breathing in Young Infants']}, 'referencesModule': {'references': [{'pmid': '27941119', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.aku.edu', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Young infant (0-59 days of age)\n* Fast breathing i.e., respiratory rate ≥60 breaths/min\n* O2 Saturation ≥90%\n* Resident of catchment area (to ensure complaint and follow up)\n* Refused hospitalization and investigations\n* Informed consent is provided by a parent (or legal guardian).\n\nExclusion Criteria:\n\n* Preterm infants (born \\<37 weeks)\n* Presence of audible murmur\n* Any concurrent signs of severe infection:\n* not feeding well\n* movement only when stimulated\n* severe chest in-drawing\n* axillary temperature ≥38.0oC or ≤35.5oC\n* Any sign of being critically ill (Cyanosis, bulging fontanel, unable to feed, unable to cry, apnoea, convulsions, unconscious, persistent vomiting)\n* Weight \\<1800gm at the time of presentation\n* Major congenital malformations or suspected chromosomal abnormalities\n* Hospitalization for illness in the last two weeks\n* Previous inclusion in the study'}, 'identificationModule': {'nctId': 'NCT01533818', 'acronym': 'MAT-YI', 'briefTitle': 'Community Based Management of Fast Breathing in Infants Aged < 60 Days in Low-income Settlements of Karachi', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Community Based Management of Fast Breathing in Infants Aged < 60 Days: A Double-Blind, Randomized Placebo-Controlled Trial in Low-income Settlements of Karachi', 'orgStudyIdInfo': {'id': '1979-CHS-ERC-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amoxicillin', 'description': 'This is an active intervention', 'interventionNames': ['Drug: Amoxicillin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar Syrup', 'interventionNames': ['Drug: Sugar Syrup']}], 'interventions': [{'name': 'Amoxicillin', 'type': 'DRUG', 'description': '80-100 mg/kg/day in 2 divided doses for 7 days\n\nFor 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', 'armGroupLabels': ['Amoxicillin']}, {'name': 'Sugar Syrup', 'type': 'DRUG', 'description': 'It will be given 2 times/day for 7 days', 'armGroupLabels': ['Sugar Syrup']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74800', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Primary Health Centers', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Shiyam Sunder P Tikmani, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aga Khan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Supervisor', 'investigatorFullName': 'Shiyam Sunder Tikmani', 'investigatorAffiliation': 'Aga Khan University'}}}}