Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT05478720
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2022-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DON in Pediatric Cerebral Malaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016779', 'term': 'Malaria, Cerebral'}, {'id': 'D008288', 'term': 'Malaria'}, {'id': 'D016778', 'term': 'Malaria, Falciparum'}], 'ancestors': [{'id': 'D020808', 'term': 'Central Nervous System Protozoal Infections'}, {'id': 'D020807', 'term': 'Central Nervous System Parasitic Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003980', 'term': 'Diazooxonorleucine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D001391', 'term': 'Azo Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009646', 'term': 'Norleucine'}, {'id': 'D000614', 'term': 'Aminocaproates'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Part 1: None (Open Label) Part 2: Blinded (Participants/ Caregivers, Study Staff)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Part 1: Adult groups Healthy / Uncomplicated Malaria - Groups of 10 adult participants will be enrolled sequentially, with safety assessment and dose escalation for each group if safety criteria are satisfied in the previous group.\n\nPediatric Arm: Enrollment of pediatric participants will begin if safety criteria are satisfied in adults previously enrolled. The pediatric study will be randomized and placebo-controlled with DON or Placebo doses added to standard of care therapy. Interim assessments are planned to determine dosing for subsequent participants.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 152}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2022-07-26', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pediatric participants: Brain volume score on MRI at admission and 24 hours (+/- 6 hours) post-randomization, if MRI is available', 'timeFrame': 'Measured at baseline and 24 hours post randomization', 'description': 'Detected by MRI'}, {'measure': 'Pediatric participants: 2. Number of minutes of electrographic seizures within the first 12 hours after DON administration', 'timeFrame': 'Measured through 12 hours post infusion', 'description': 'Detected by continuous EEG monitoring'}, {'measure': 'Pediatric participants: EEG power analysis', 'timeFrame': 'Measured at baseline and through 12 hours post infusion', 'description': 'Detected by 30 minute EEG samples analyzing power at baseline and 3, 6, and 12 hours post infusion'}, {'measure': 'Pediatric participants: EEG amplitude analysis', 'timeFrame': 'Measured at baseline and through 12 hours post infusion', 'description': 'Detected by 30 minute EEG samples analyzing amplitude at baseline and 3, 6, and 12 hours post infusion'}, {'measure': 'Pediatric participants: EEG frequency analysis', 'timeFrame': 'Measured at baseline and through 12 hours post infusion', 'description': 'Detected by 30 minute EEG samples analyzing frequency at baseline and 3, 6, and 12 hours post infusion'}, {'measure': 'Pediatric participants: Transcranial Doppler (TCD) phenotype flow velocities', 'timeFrame': 'Measured through 24 hours post infusion', 'description': 'Detected by TCD at 4H and 24H post infusion'}, {'measure': 'Pediatric participants: Cerebrospinal Fluid Metabolic Profile', 'timeFrame': 'Measured through 4 hours post infusion', 'description': 'Detected by LP at baseline and 4H (+ or - 2H) post DON infusion'}], 'primaryOutcomes': [{'measure': 'Incidence of local AEs occurring within 14 days after the administration of DON', 'timeFrame': '14 days', 'description': 'Number of AEs'}, {'measure': 'Incidence of systemic AEs occurring within 14 days after the administration of DON', 'timeFrame': '14 days', 'description': 'Number of AEs'}, {'measure': 'Incidence of systemic SAEs occurring within 14 days after the administration of DON', 'timeFrame': '14 days', 'description': 'Number of SAEs - pediatric arms only'}], 'secondaryOutcomes': [{'measure': 'PK measurement of DON in sera of recipients measured by half life', 'timeFrame': 'Measured through 18 hours post infusion', 'description': 'Measurement of half life'}, {'measure': 'PK measurement of DON in sera of recipients measured by volume of distribution', 'timeFrame': 'Measured through 18 hours post infusion', 'description': 'Measurement of Vd'}, {'measure': 'PK measurement of DON in sera of recipients measure by maximum concentration (Cmax)', 'timeFrame': 'Measured through 18 hours post infusion', 'description': 'Measurement of Cmax'}, {'measure': 'PK measurement of DON in sera of recipients measure by time of maximal concentration (Tmax)', 'timeFrame': 'Measured through 18 hours post infusion', 'description': 'Measurement of Tmax'}, {'measure': 'PK measurement of DON in sera of recipients measure by area under the concentrations vs. time curve (AUC)', 'timeFrame': 'Measured through 18 hours post infusion', 'description': 'Measurement of AUC'}, {'measure': 'PK measurement of DON in sera of recipients measure by clearance', 'timeFrame': 'Measured through 18 hours post infusion', 'description': 'Clearance measured over time'}, {'measure': 'PK measurement of DON in sera of recipients measure by elimination rate', 'timeFrame': 'Measured through 18 hours post infusion', 'description': 'Elimination over time'}, {'measure': 'PK measurement of DON in sera of recipients measure by terminal T1/2', 'timeFrame': 'Measured through 18 hours post infusion', 'description': 'Measurement of terminal T1/2'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['malaria', 'Plasmodium falciparum'], 'conditions': ['Malaria, Cerebral']}, 'referencesModule': {'references': [{'pmid': '38279124', 'type': 'DERIVED', 'citation': "Nampota-Nkomba N, Nyirenda OM, Mallewa J, Chimalizeni Y, Dzabala N, Fay MP, Gopalakrishnan M, Laurens MB, O'Brien NF, Miller LH, Pierce SK, Riggle BA, Postels DG. DON in pediatric cerebral malaria, a phase I/IIA dose-escalation safety study: study protocol for a clinical trial. Trials. 2024 Jan 26;25(1):87. doi: 10.1186/s13063-023-07808-w."}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the safety of a single intravenous dose of DON in healthy adults, adults with uncomplicated malaria, and children 12 months-14 years old with clinically defined Cerebral Malaria. The main objectives are:\n\n* Determine the pharmacokinetic (PK) profile of a single dose of DON in children with CM\n* Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with CM is associated with improved intracerebral blood flow dynamics on transcranial doppler (TCD)\n* Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with CM is associated with a reduction in brain volume score on magnetic resonance imaging (MRI)\n* Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with cerebral malaria is associated with changes in electroencephalogram (EEG) pattern\n* Exploratory: Explore the metabolic mechanisms of action of adjunctive DON in children with CM\n\nHealthy adult participants will receive:\n\n* anti-emetic ondansetron\n* one dose of DON\n\nAdults with uncomplicated malaria will receive:\n\n* anti-emetic ondansetron\n* one dose of DON\n* artemisinin-combination therapies per Malawi Ministry of Health guidelines\n\nPediatric participants will receive:\n\n* one dose of DON\n* anti-emetic ondansetron and per Malawi Ministry of Health guidelines:\n* enteral lumefantrine-artemether therapy, and\n* artesunate therapy', 'detailedDescription': 'The initial study to be conducted under this IND is a 2 part dose escalation study. The first part contains 2 groups that will be open-label, dose escalation, and will define the safety of 6-diazo-5-oxo-L-norleucine (DON) in African adults (\\>18 years old), who are healthy or who have uncomplicated malaria.\n\nEach of the two adult groups will enroll 40 participants broken down into 4 dosage groups with safety evaluations before each dose increase. The first 10 participants enrolled will receive 0.1 mg/kg intravenous (IV) DON. If this dose is proven safe, the dose will be increased to 1.0 mg/kg IV DON, and then 5.0 mg/kg IV DON, and then the final group will receive 10.0 mg/kg IV DON. Each adult dosage group contains 10 healthy participants and 10 participants with uncomplicated malaria. The total number of adult participants enrolled is 80 (20 participants at 4 doses). All participants will receive only one dose of DON.\n\nAdult participants will receive a premedication dose of the antiemetic ondansetron, 5 mg IV, administered 30 minutes prior to DON, and repeated 8 and 16 hours later. The duration of study participation for all adult participants is six months.\n\nPart 2 of the study will be a randomized, placebo-controlled, dose-escalation study in children ages 12 months to 14 years with cerebral malaria to determine safety. Pediatric enrollments will span three malaria seasons, which will be carried out in Study Years 3-5, with a planned interim analysis after cohort 3. In cohort 1 we will first enroll 6 sentinel pediatric participants who will receive intravenous artesunate therapy, enteral lumefantrine-artemether therapy, and either adjunctive DON 0.1 mg/kg or placebo randomized 2:1. Cohort 2 will enroll 12 participants who will receive intravenous artesunate therapy, enteral lumefantrine-artemether therapy, and either adjunctive DON 0.1 mg/kg or placebo randomized 5:1.Cohort 3 will enroll 18 participants who will receive intravenous artesunate therapy, enteral lumefantrine-artemether therapy, and either adjunctive DON 1.0 mg/kg or placebo randomized 7:1. Cohort 4 will enroll 36 participants who will receive intravenous artesunate therapy, enteral lumefantrine-artemether therapy, and either adjunctive DON 0.1 mg/kg, DON 1.0 mg/kg or placebo randomized 1:1:1. Pediatric participation in the study will be 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor Healthy Adults (Arm 1):\n\n* 18 years and older\n* Informed consent obtained and ICF signed\n* Temperature ≤ 37.5 °C\n* BMI 18.5-25 kg/m2\n* Creatinine ≤ 110 mmol/L (≤ 1.2 mg/dL; males) or ≤ 90 mmol/L (≤ 1.0 mg/dL; females)\n* Hemoglobin ≥ 7 g/dL or hematocrit/ packed-cell volume (PCV) ≥ 20%\n* Thick or thin blood smear negative for asexual forms of P. falciparum\n* Negative pregnancy test for persons of child-bearing potential\n\nFor Adults with Uncomplicated Malaria (Arm 2):\n\n* 18 years and older\n* Informed consent obtained and ICF signed\n* Temperature ≥ 38 °C or history of fever in the past 24 hours\n* Thick or thin blood smear positive for asexual forms of P. falciparum (parasite count and speciation documented)\n* Hemoglobin ≥ 7 g/dL or hematocrit/ PCV ≥ 20%\n* BMI 18.5-25 kg/m2\n* Creatinine ≤ 110 mmol/L (≤ 1.2 mg/dL; males) or ≤ 90 mmol/L (≤ 1.0 mg/dL; females)\n* Glasgow coma score of 15\n* Respiratory rate ≤ 20 breaths/ minute\n* Oxygen saturation ≥ 90% on room air\n* Negative pregnancy test for person of child-bearing potential\n\nFor Children with Cerebral Malaria (Arm 3):\n\n* Age 12 months-14 years old\n* Informed consent obtained and ICF signed by parent or guardian\n* Temperature ≥ 38 °C or history of fever in the last 24 hours\n* Thick or thin blood smear positive for asexual forms of P. falciparum\n* Blantyre coma score ≤ 2\n* No other explanation for coma by history or physical exam\n* Hematocrit or PCV ≥ 18%\n* Negative pregnancy test for persons of child-bearing potential\n* Creatinine ≤ 1.5 mg/dL\n* Aspartate aminotransferase (AST) \\< 280 IU/L\n* Alanine aminotransferase (ALT) \\< 195 IU/L\n\nExclusion Criteria (All Participants):\n\n* Pregnancy or lactation (participants of child-bearing potential ages 9-59 years will undergo pregnancy testing prior to administration of the intervention)\n* Participants attempting to become pregnant\n* Currently taking highly active antiretroviral therapy (HAART)\n* Currently taking anti-tuberculosis medications\n* Allergy to ondansetron\n\nAdditional Exclusion Criteria for Children with Cerebral Malaria (Arm 3):\n\n* Cloudy cerebrospinal fluid (indicative of a probable bacterial central nervous system infection)\n* Malnutrition defined as a more than or equal to two standard deviations below the mean weight for height and/ or MUAC ≤ 12.5 cm (due to inability to adequately care for children with severe malnutrition on the PRW)\n* Allergy to ondansetron or ceftriaxone\n* Coma for \\> 72 hours\n* Have taken a CYP3A4 inhibitor within 7 days of enrollment'}, 'identificationModule': {'nctId': 'NCT05478720', 'briefTitle': 'DON in Pediatric Cerebral Malaria', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'DON in Pediatric Cerebral Malaria: A Phase I/IIa Dose-Escalation Safety Study', 'orgStudyIdInfo': {'id': '21/04/2676'}, 'secondaryIdInfos': [{'id': '21-0005', 'type': 'OTHER', 'domain': 'DMID'}, {'id': 'PAR-18-633', 'type': 'OTHER_GRANT', 'domain': 'DMID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose escalation in healthy Malawian adults - 0.1 mg/kg IV DON', 'description': 'The first 10 healthy adult participants enrolled will receive a single 0.1 mg/kg intravenous (IV) DON. If this dose is proven safe, in each subsequent group of 10, the dose will be increased to 1.0 mg/kg IV DON and then 5.0 mg/kg IV DON the final group will receive 10.0 mg/kg IV DON.', 'interventionNames': ['Drug: 6-diazo-5-oxo-L-norleucine (DON)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose escalation in healthy Malawian adults - 1.0 mg/kg IV DON', 'description': 'The first 10 healthy adult participants enrolled will receive a single 0.1 mg/kg intravenous (IV) DON. If this dose is proven safe, in each subsequent group of 10, the dose will be increased to 1.0 mg/kg IV DON and then 5.0 mg/kg IV DON the final group will receive 10.0 mg/kg IV DON.', 'interventionNames': ['Drug: 6-diazo-5-oxo-L-norleucine (DON)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose escalation in healthy Malawian adults - 5.0 mg/kg IV DON', 'description': 'The first 10 healthy adult participants enrolled will receive a single 0.1 mg/kg intravenous (IV) DON. If this dose is proven safe, in each subsequent group of 10, the dose will be increased to 1.0 mg/kg IV DON and then 5.0 mg/kg IV DON the final group will receive 10.0 mg/kg IV DON.', 'interventionNames': ['Drug: 6-diazo-5-oxo-L-norleucine (DON)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose escalation in healthy Malawian adults - 10.0 mg/kg IV DON', 'description': 'The first 10 healthy adult participants enrolled will receive a single 0.1 mg/kg intravenous (IV) DON. If this dose is proven safe, in each subsequent group of 10, the dose will be increased to 1.0 mg/kg IV DON and then 5.0 mg/kg IV DON the final group will receive 10.0 mg/kg IV DON.', 'interventionNames': ['Drug: 6-diazo-5-oxo-L-norleucine (DON)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose escalation in Malawian adults with uncomplicated malaria - 0.1 mg/kg IV DON', 'description': 'The first 10 adults with uncomplicated malaria participants enrolled will receive a single 0.1 mg/kg intravenous (IV) DON. If this dose is proven safe, in each subsequent group of 10, the dose will be increased to 1.0 mg/kg IV DON and then 5.0 mg/kg IV DON, and then the final group will receive 10.0 mg/kg IV DON.', 'interventionNames': ['Drug: 6-diazo-5-oxo-L-norleucine (DON)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose escalation in Malawian adults with uncomplicated malaria - 1.0 mg/kg IV DON', 'description': 'The first 10 adults with uncomplicated malaria participants enrolled will receive a single 0.1 mg/kg intravenous (IV) DON. If this dose is proven safe, in each subsequent group of 10, the dose will be increased to 1.0 mg/kg IV DON and then 5.0 mg/kg IV DON, and then the final group will receive 10.0 mg/kg IV DON.', 'interventionNames': ['Drug: 6-diazo-5-oxo-L-norleucine (DON)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose escalation in Malawian adults with uncomplicated malaria - 5.0 mg/kg IV DON', 'description': 'The first 10 adults with uncomplicated malaria participants enrolled will receive a single 0.1 mg/kg intravenous (IV) DON. If this dose is proven safe, in each subsequent group of 10, the dose will be increased to 1.0 mg/kg IV DON and then 5.0 mg/kg IV DON, and then the final group will receive 10.0 mg/kg IV DON.', 'interventionNames': ['Drug: 6-diazo-5-oxo-L-norleucine (DON)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose escalation in Malawian adults with uncomplicated malaria - 10.0 mg/kg IV DON', 'description': 'The first 10 adults with uncomplicated malaria participants enrolled will receive a single 0.1 mg/kg intravenous (IV) DON. If this dose is proven safe, in each subsequent group of 10, the dose will be increased to 1.0 mg/kg IV DON and then 5.0 mg/kg IV DON, and then the final group will receive 10.0 mg/kg IV DON.', 'interventionNames': ['Drug: 6-diazo-5-oxo-L-norleucine (DON)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose escalation in Malawian children with cerebral malaria - 0.1 mg/kg IV DON - Cohort 1', 'description': 'After adult doses are shown to be safe. Of the first 6 children with cerebral malaria enrolled, 4 will receive 0.1 mg/kg IV DON, and 2 will receive placebo.', 'interventionNames': ['Drug: 6-diazo-5-oxo-L-norleucine (DON)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose escalation in Malawian children with cerebral malaria - 0.1 mg/kg IV DON - Cohort 2', 'description': '10 participants will receive 0.1 mg/kg IV DON, and 2 will receive placebo.', 'interventionNames': ['Drug: 6-diazo-5-oxo-L-norleucine (DON)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose escalation in Malawian children with cerebral malaria - 1.0 mg/kg IV DON - Cohort 3', 'description': '14 participants will receive 1.0 mg/kg IV DON, and 4 will receive placebo.', 'interventionNames': ['Drug: 6-diazo-5-oxo-L-norleucine (DON)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose escalation in Malawian children with cerebral malaria - 0.1 or 1.0 mg/kg IV DON - Cohort 4', 'description': '36 participants will receive 0.1 mg/kg IV DON (n=12) or 1.0 mg/kg IV DON (n=12), and 12 will receive placebo.', 'interventionNames': ['Drug: 6-diazo-5-oxo-L-norleucine (DON)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dose escalation in Malawian children with cerebral malaria - placebo', 'description': 'Cohort 1 will dose 2 participants to receive placebo Cohort 2 will dose 2 participants to receive placebo Cohort 3 will dose 4 participants to receive placebo Cohort 4 will dose 12 participants to receive placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '6-diazo-5-oxo-L-norleucine (DON)', 'type': 'DRUG', 'otherNames': ['NSC 7365'], 'description': 'Single intravenous dose ranging from 0.1-10 mg/kg per dose', 'armGroupLabels': ['Dose escalation in Malawian adults with uncomplicated malaria - 0.1 mg/kg IV DON', 'Dose escalation in Malawian adults with uncomplicated malaria - 1.0 mg/kg IV DON', 'Dose escalation in Malawian adults with uncomplicated malaria - 10.0 mg/kg IV DON', 'Dose escalation in Malawian adults with uncomplicated malaria - 5.0 mg/kg IV DON', 'Dose escalation in healthy Malawian adults - 0.1 mg/kg IV DON', 'Dose escalation in healthy Malawian adults - 1.0 mg/kg IV DON', 'Dose escalation in healthy Malawian adults - 10.0 mg/kg IV DON', 'Dose escalation in healthy Malawian adults - 5.0 mg/kg IV DON']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'Single intravenous dose of saline', 'armGroupLabels': ['Dose escalation in Malawian children with cerebral malaria - placebo']}, {'name': '6-diazo-5-oxo-L-norleucine (DON)', 'type': 'DRUG', 'otherNames': ['NSC 7365'], 'description': 'Single intravenous dose ranging from 0.1-1.0 mg/kg per dose', 'armGroupLabels': ['Dose escalation in Malawian children with cerebral malaria - 0.1 mg/kg IV DON - Cohort 1', 'Dose escalation in Malawian children with cerebral malaria - 0.1 mg/kg IV DON - Cohort 2', 'Dose escalation in Malawian children with cerebral malaria - 0.1 or 1.0 mg/kg IV DON - Cohort 4', 'Dose escalation in Malawian children with cerebral malaria - 1.0 mg/kg IV DON - Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blantyre', 'status': 'COMPLETED', 'country': 'Malawi', 'facility': 'Ndirande Research Clinic', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}, {'city': 'Blantyre', 'status': 'RECRUITING', 'country': 'Malawi', 'contacts': [{'name': 'Yamikani Chimalizeni, MD', 'role': 'CONTACT', 'email': 'ychimalizeni@medcol.mw', 'phone': '+265 992 23 32 21'}, {'name': 'Douglas Postels, MD', 'role': 'CONTACT', 'email': 'dpostels@childrensnational.org', 'phone': '+265 995 83 32 73'}], 'facility': 'Queen Elizabeth Central Hospital', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}], 'centralContacts': [{'name': 'Yamikani Chimalizeni, MD', 'role': 'CONTACT', 'email': 'ychimalizeni@medcol.mw', 'phone': '+265 992 23 32 21'}, {'name': 'Alice Liomba', 'role': 'CONTACT', 'email': 'wanguialice@gmail.com', 'phone': '+265 888 36 57 58'}], 'overallOfficials': [{'name': 'Douglas Postels, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's National Research Institute"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Douglas Postels, MD, MS', 'class': 'UNKNOWN'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatric Neurology', 'investigatorFullName': 'Douglas Postels', 'investigatorAffiliation': "Children's National Research Institute"}}}}