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3 results on '"Namayanja C"'

1. PARIST study protocol: a phase I/II randomised, controlled clinical trial to assess the feasibility, safety and effectiveness of paracetamol in resolving acute kidney injury in children with severe malaria.

Author

Paasi G, Okalebo CB, Ongodia P, Namayanja C, Eregu EEI, Abongo G, Olupot M, Amorut D, Muhindo R, Okiror W, Ndila C, and Olupot-Olupot P

Subjects
Humans, Child, Acetaminophen therapeutic use, Feasibility Studies, Uganda, Treatment Outcome, Randomized Controlled Trials as Topic, Clinical Trials, Phase I as Topic, Clinical Trials, Phase II as Topic, Malaria drug therapy, Malaria, Falciparum complications, Malaria, Falciparum drug therapy, Acute Kidney Injury drug therapy, Acute Kidney Injury complications
Abstract

Background: Acute kidney injury (AKI) has in the past been considered a rare complication of malaria in children living in high-transmission settings. More recently, however, a growing number of paediatric case series of AKI in severe malaria studies in African children have been published (Artesunate vs Quinine in the Treatment of Severe P. falciparum Malaria in African children and Fluids Expansion as Supportive Therapy trials). The Paracetamol for Acute Renal Injury in Severe Malaria Trial (PARIST) therefore, aims to assess feasibility, safety and determine the effective dose of paracetamol, which attenuates nephrotoxicity of haemoproteins, red-cell free haemoglobin and myoglobin in children with haemoglobinuric severe malaria., Methods: PARIST is a phase I/II unblinded randomised controlled trial of 40 children aged >6 months and <12 years admitted with confirmed haemoglobinuric severe malaria (blackwater fever), a positive blood smear for P. falciparum malaria and either serum creatinine (Cr) increase by ≥0.3 mg/dL within 48 hours or to ≥1.5 times baseline and elevated blood urea nitrogen (BUN) >20 mg/dL. Children will be randomly allocated on a 1:1 basis to paracetamol intervention dose arm (20 mg/kg orally 6-hourly for 48 hours) or to a control arm to receive standard of care for temperature control (ie, tepid sponging for 30 min if fever persists give rescue treatment). Primary outcome is renal recovery at 48 hours as indicated by stoppage of progression and decrease of Cr level below baseline, BUN (<20 mg/dL). Data analysis will be on the intention-to-treat principle and a per-protocol basis.Results from this phase I/II clinical trial will provide preliminary effectiveness data of this highly potential treatment for AKI in paediatric malaria (in particular for haemoglobinuric severe malaria) for a larger phase III trial., Ethics and Dissemination: Ethical and regulatory approvals have been granted by the Mbale Hospital Institutional Ethics Review Committee (MRRH-REC OUT 002/2019), Uganda National Council of Science and Technology (UNCST-HS965ES) and the National drug Authority (NDA-CTC 0166/2021). We will be disseminating results through journals, conferences and policy briefs to policy makers and primary care providers., Trial Registration Number: ISRCTN84974248., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2023
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2. Transfusion Volume for Children with Severe Anemia in Africa

Author

Maitland, K, Saunders, D, Olupot-Olupot, P, Kiguli, S, Chagaluka, G, Alaroker, F, Opoka, OR, Mpoya, A, Engoru, C, Nteziyaremye, J, Mallewa, M, Kennedy, N, Nakuya, M, Namayanja, C, Kayaga, J, Uyoga, S, Byabazaire, D, M’baya, B, Wabwire, B, Frost, G, Bates, I, Evans, JA, Williams, TN, Goncalves, P, George, EC, Gibb, DM, Walker, AS, Group, for the TRACT, Medical Research Council, Medical Research Council, UK, and Medical Research Council (MRC)

Subjects
Male, Malawi, Pediatrics, Blood transfusion, Cost-Benefit Analysis, medicine.medical_treatment, 030204 cardiovascular system & hematology, Transfusion volume, TRACT Group, Hemoglobins, 0302 clinical medicine, Uganda, 030212 general & internal medicine, Child, 11 Medical and Health Sciences, wh_155, Anemia, Health Care Costs, General Medicine, ws_300, Child, Preschool, Hospital admission, Female, Life Sciences & Biomedicine, medicine.medical_specialty, Fever, Patient Readmission, World health, Severe anemia, wb_356, 03 medical and health sciences, Medicine, General & Internal, SDG 3 - Good Health and Well-being, General & Internal Medicine, parasitic diseases, medicine, Humans, Blood Transfusion, Science & Technology, business.industry, Infant, Transfusion Reaction, Length of Stay, medicine.disease, Malaria, Hemoglobin, business, Follow-Up Studies
Abstract

Background: Severe anemia (hemoglobin level, Methods: In this factorial, open-label trial, we randomly assigned Ugandan and Malawian children 2 months to 12 years of age with a hemoglobin level of less than 6 g per deciliter and severity features (e.g., respiratory distress or reduced consciousness) to receive immediate blood transfusion with 20 ml per kilogram or 30 ml per kilogram. Three other randomized analyses investigated immediate as compared with no immediate transfusion, the administration of postdischarge micronutrients, and postdischarge prophylaxis with trimethoprim–sulfamethoxazole. The primary outcome was 28-day mortality.Results: A total of 3196 eligible children (median age, 37 months; 2050 [64.1%] with malaria) were assigned to receive a transfusion of 30 ml per kilogram (1598 children) or 20 ml per kilogram (1598 children) and were followed for 180 days. A total of 1592 children (99.6%) in the higher-volume group and 1596 (99.9%) in the lower-volume group started transfusion (median, 1.2 hours after randomization). The mean (±SD) volume of total blood transfused per child was 475±385 ml and 353±348 ml, respectively; 197 children (12.3%) and 300 children (18.8%) in the respective groups received additional transfusions. Overall, 55 children (3.4%) in the higher-volume group and 72 (4.5%) in the lower-volume group died before 28 days (hazard ratio, 0.76; 95% confidence interval [CI], 0.54 to 1.08; P=0.12 by log-rank test). This finding masked significant heterogeneity in 28-day mortality according to the presence or absence of fever (>37.5°C) at screening (P=0.001 after Sidak correction). Among the 1943 children (60.8%) without fever, mortality was lower with a transfusion volume of 30 ml per kilogram than with a volume of 20 ml per kilogram (hazard ratio, 0.43; 95% CI, 0.27 to 0.69). Among the 1253 children (39.2%) with fever, mortality was higher with 30 ml per kilogram than with 20 ml per kilogram (hazard ratio, 1.91; 95% CI, 1.04 to 3.49). There was no evidence of differences between the randomized groups in readmissions, serious adverse events, or hemoglobin recovery at 180 days.Conclusions: Overall mortality did not differ between the two transfusion strategies. (Funded by the Medical Research Council and Department for International Development, United Kingdom; TRACT Current Controlled Trials number, ISRCTN84086586.)

Published
2019
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3. Cotrimoxazole or multi-mineral multi-vitamins to improve post-discharge outcomes following severe anaemia in African children: a randomised controlled trial

Author

Maitland, K, Olupot-Olupot, P, Kiguli, S, Chagaluka, G, Alaroker, F, Opoka, R, Mpoya, A, Walsh, K, Engoru, C, Nteziyaremye, J, Mallewa, M, Kennedy, N, Nakuya, M, Namayanja, C, Kayaga, J, Nabawanuka, E, Sennyondo, T, Aromut, D, Kumwenda, F, Williams Musika, C, Thomason, M, Bates, I, Boele Von Hensbroek, M, Evans, J, Uyoya, S, Williams, T, Frost, G, George, E, Gibb, D, Walker, A, Medical Research Council (MRC), Medical Research Council, Medical Research Council, UK, Imperial College Healthcare NHS Trust- BRC Funding, and Engineering & Physical Science Research Council (EPSRC)

Subjects
SPRINKLES, YOUNG-CHILDREN, Malawi, Science & Technology, IRON FORTIFICATION, MORTALITY, Infant, Anemia, PROPHYLAXIS, Patient Discharge, TRACT trial group, 1117 Public Health and Health Services, DEFICIENCY, DOUBLE-BLIND, MALARIA, TRANSFUSION, INFECTION, Dietary Supplements, Trimethoprim, Sulfamethoxazole Drug Combination, Humans, Uganda, Child, Life Sciences & Biomedicine, Public, Environmental & Occupational Health, 0605 Microbiology
Abstract

Background: Severe anaemia (haemoglobin0.2). By day180, 489(24%) MVMM vs 509(26%) iron/folate had experienced one or more SAEs (HR=0.95 (0.84- 1.07), p=0.40) and 500(25%) cotrimoxazole vs 498(25%) no cotrimoxazole (HR=1.01 (0.89,1.15) p=0.85). Most SAEs were readmissions, occurring in 692(17%) children (175(4%) with ≥2 readmissions). Interpretation: Neither enhanced supplementation with MVMM versus iron/folate treatment or cotrimoxazole prophylaxis improved 6-month survival. High rates of hospital re-admission suggest that novel interventions are urgently required for severe anaemia, given the burden it places on overstretched health services in Africa.

Published
2019

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