Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-29 @ 12:41 PM
Study NCT ID:
NCT02451904
Status:
COMPLETED
Last Update Posted:
2018-06-20
First Post:
2015-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severe and Cerebral Malaria Investigated Through Host Metabolomics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, Urine, CSF, Stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 840}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-19', 'studyFirstSubmitDate': '2015-05-15', 'studyFirstSubmitQcDate': '2015-05-19', 'lastUpdatePostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterisation of patterns of metabolic dysregulation in severe malaria', 'timeFrame': '4-6 weeks', 'description': 'Interrelationship between disturbances in metabolic pathways associated with acidosis and cerebral malaria'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pathogenesis', 'Microvascular function', 'Metabolic dysregulation', 'Metabolomics'], 'conditions': ['Severe Malaria']}, 'referencesModule': {'references': [{'pmid': '16125588', 'type': 'BACKGROUND', 'citation': 'Dondorp A, Nosten F, Stepniewska K, Day N, White N; South East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT) group. Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial. Lancet. 2005 Aug 27-Sep 2;366(9487):717-25. doi: 10.1016/S0140-6736(05)67176-0.'}, {'pmid': '21062666', 'type': 'BACKGROUND', 'citation': 'Dondorp AM, Fanello CI, Hendriksen IC, Gomes E, Seni A, Chhaganlal KD, Bojang K, Olaosebikan R, Anunobi N, Maitland K, Kivaya E, Agbenyega T, Nguah SB, Evans J, Gesase S, Kahabuka C, Mtove G, Nadjm B, Deen J, Mwanga-Amumpaire J, Nansumba M, Karema C, Umulisa N, Uwimana A, Mokuolu OA, Adedoyin OT, Johnson WB, Tshefu AK, Onyamboko MA, Sakulthaew T, Ngum WP, Silamut K, Stepniewska K, Woodrow CJ, Bethell D, Wills B, Oneko M, Peto TE, von Seidlein L, Day NP, White NJ; AQUAMAT group. Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an open-label, randomised trial. Lancet. 2010 Nov 13;376(9753):1647-57. doi: 10.1016/S0140-6736(10)61924-1. Epub 2010 Nov 7.'}, {'pmid': '30566600', 'type': 'DERIVED', 'citation': 'Leopold SJ, Ghose A, Allman EL, Kingston HWF, Hossain A, Dutta AK, Plewes K, Chotivanich K, Day NPJ, Tarning J, Winterberg M, White NJ, Llinas M, Dondorp AM. Identifying the Components of Acidosis in Patients With Severe Plasmodium falciparum Malaria Using Metabolomics. J Infect Dis. 2019 May 5;219(11):1766-1776. doi: 10.1093/infdis/jiy727.'}]}, 'descriptionModule': {'briefSummary': '* The aim is to describe disease mechanisms of severe and cerebral malaria and identify new targets for adjunctive therapies.\n* Despite treatment between 10-30% of patients with severe malaria die.\n* Metabolic acidosis and cerebral malaria are major complications associated with mortality across all age groups. Still, their underlying pathogenesis remains incompletely understood.\n* Using a metabolomics approach, this study aims to characterise the spectrum of acids accumulating during acidosis, and investigate patterns of metabolic dysregulation associated with coma and seizures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In total, up to 840 patients may be enrolled in this study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Severe/Cerebral Malaria:\n\n* Any P. falciparum parasitaemia detected by asexual stages on a peripheral blood-slide or a positive rapid diagnostic test in combination with one or more Modified WHO Criteria for Severe Malaria (Hien et al, 1996)\n* \\< 24 hours after treatment commencement with either parenteral artemisinin or quinine\n* Age \\> 12 years\n* Full informed written consent obtained\n\nUncomplicated malaria:\n\n* Any level of Plasmodium parasitaemia, detected by asexual stages on a peripheral blood-slide or a positive rapid diagnostic test without any of the complications of severe malaria stated above.\n* Age \\> 12 years\n* Full informed written consent obtained\n\nSepsis:\n\n* Clinical signs of infection in combination with any two of the following signs:\n\n 1. Heart rate \\> 90 beats per minute;\n 2. Respiratory rate \\> 20 breaths per minute, a PaCO2 of \\< 32 mmHg, or the use of mechanical ventilation for an acute respiratory process;\n 3. Tympanic temperature \\> 38°C or \\< 36 °C;\n 4. White-cell count of \\> 12x109/L or \\< 4x109/L, or a differential count showing 10% immature neutrophils ;\n* Negative peripheral blood slide for any stages of malaria parasites or a negative rapid diagnostic test for falciparum and vivax malaria\n* \\[As bacterial culture is not routinely available at the study site, positivity of cultures is not required\\]\n* Age \\> 12 years\n* Full informed written consent obtained\n\nAcidosis:\n\n* Clinical suspicion of metabolic acidosis in combination with any of the following:\n\n 1. Peripheral venous bicarbonate \\< 15 mmol/L\n 2. Peripheral venous base excess \\< -3 mmol/L\n* Negative peripheral blood slide for any stages of malaria parasites or a negative rapid diagnostic test for falciparum and vivax malaria; and not meeting any of the inclusion criteria for sepsis as stated above.\n* Age \\> 12 years\n* Full informed written consent obtained\n\nEncephalitis:\n\n* GCS \\< 11/15\n* Documented fever \\> 38°C\n* Onset of symptoms \\< 2 weeks, with an indication a lumbar puncture as part of the diagnostic work up\n* Negative peripheral blood slide for any stages of malaria parasites or a negative rapid diagnostic test for falciparum and vivax malaria\n* Age \\> 12 years\n* Full informed written consent obtained\n\nHealthy volunteers:\n\n* No chronic or acute disease\n* No fever in the past 2 weeks\n* Age \\> 16 years\n* Full informed written consent obtained\n\nExclusion Criteria:\n\n* Known pre-existing chronic medical conditions including advanced hepatic disease.'}, 'identificationModule': {'nctId': 'NCT02451904', 'briefTitle': 'Severe and Cerebral Malaria Investigated Through Host Metabolomics', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Microvascular and Metabolic Dysregulation in the Pathogenesis of Severe and Cerebral Malaria Investigated Through Host Metabolomics', 'orgStudyIdInfo': {'id': 'BAKMAL1407'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Severe/Cerebral Malaria', 'description': 'Intensive monitoring', 'interventionNames': ['Other: Observation']}, {'label': 'Uncomplicated Malaria', 'description': 'Intensive monitoring', 'interventionNames': ['Other: Observation']}, {'label': 'Sepsis', 'description': 'Intensive monitoring', 'interventionNames': ['Other: Observation']}, {'label': 'Acidosis', 'description': 'Intensive monitoring', 'interventionNames': ['Other: Observation']}, {'label': 'Encephalitis', 'description': 'Intensive monitoring', 'interventionNames': ['Other: Observation']}, {'label': 'Healthy Individuals', 'description': 'Monitoring', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'armGroupLabels': ['Acidosis', 'Encephalitis', 'Healthy Individuals', 'Sepsis', 'Severe/Cerebral Malaria', 'Uncomplicated Malaria']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chittagong', 'country': 'Bangladesh', 'facility': 'Chittagong Medical College Hospital (CMCH)', 'geoPoint': {'lat': 22.3384, 'lon': 91.83168}}], 'overallOfficials': [{'name': 'Prof. Arjen M. Dondorp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol Oxford Tropical Medicine Research Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chittagong Medical College and Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}