Efficacy and safety of dual intravenous artesunate plus quinine compared to intravenous artesunate for cerebral malaria in a triple blinded parallel multisite randomized controlled trial in Nigerian children: DUAL PAQ TRIAL Protocol.

BACKGROUND: Evidence exists as to the criticality of the first 24 h in the management of cerebral malaria. The morbidity and the mortality rate (35%) with the current intravenous monotherapy for the initial treatment of cerebral malaria are unacceptably high. Combination therapy and a shorter course of effective medication have been shown to improve outcomes in human participants in the treatment of other diseases. This study outlines a protocol to conduct a triple blinded parallel randomized controlled trial on cerebral malaria using dual intravenous medications compared to the current standard of monotherapy. METHODS: This is a parallel multi-site randomized controlled superiority triple blinded trial consisting of intravenous artesunate plus quinine and a control arm of intravenous artesunate only. Eligible and assenting children aged 6 months to 17 years will be recruited from 4 tertiary hospitals by random selection from the list of tertiary hospitals in Nigeria. Participants will be randomized and assigned in parallel into two arms using random numbers generated from GraphPad Prism (version 9) by a clinical pharmacologist who has no link with the investigators, the patients, or the statistician. The primary measurable outcome is survival at 12, 24, and 48 h post-randomization. A composite secondary outcome consists of the number of children that regained consciousness, parasitaemia and defervescence at 12 and 24 h post-randomization and haematological and inflammatory markers at 24 and 48 h post-randomization. Adverse events both solicited and unsolicited are recorded all through the study post-randomization. The study is approved by the State Research Ethics Review Committee. Data analysis will be performed in GraphPad Prism version 9. DISCUSSION: The outcome of this analysis will give insight into the efficacy and safety of dual intravenous antimalaria in the treatment of cerebral malaria among Nigerian children compared with the standard of care. The safety profile of this intervention will also be highlighted. This may help inform physicians on the optimal treatment for cerebral malaria to improve outcomes and reduce recrudescence and treatment failure. TRIAL REGISTRATION: Pan Africa Clinical Trial Registry PACTR202102893629864 . 23/02/2021.

Hemoglobin SS Nigerian Woman First Diagnosed at the Age of 52 years with Manifestation Mimicking Tuberculosis of the Spine.

Sickle cell anemia (SCA) is an inherited disorder of hemoglobin due to the presence of abnormal hemoglobin in a homozygous state. Manifestation is usually in infancy or early childhood due to gradual decrease in hemoglobin F level as age advances. Diagnosis in middle age is unusual. We present a woman who was diagnosed of SCA for the first time at middle age. The aim was to bring to the knowledge of physicians that patients with SCA can also present late so high index of suspicion is required to make diagnosis. A 52-year-old woman presented to orthopedic clinic with complaints of generalized bone pain and low back pain. There was no history of trauma prior to the onset of the pain. There was no associated fever, weight loss, loss of appetite, nor weakness of the lower limbs. X-ray of the spine done showed wedge collapse of the 12th thoracic and first lumbar vertebrae with posterior angulation of the thoracolumbar junction giving dorsal kyphosis. Her mode of presentation raised a suspicion of tuberculosis of the spine to rule out multiple myeloma. However, investigations for tuberculosis and multiple myeloma were all negative. This necessitated the investigation for SCA and the diagnosis was confirmed. The diagnosis of SCA is usually made in infancy or early childhood. High index of suspicion is required to make the diagnosis at middle age.

Burden of care amongst caregivers who are first degree relatives of patients with schizophrenia.

INTRODUCTION: Caring for a mentally ill family member is a challenging task. Caregivers who are first-degree relatives (FDR) are at a higher risk of experiencing the negative consequences of caregiving. This study was aimed at determining burden of care and its correlates in caregivers who are first-degree relatives of patients with schizophrenia. METHODS: A dyad of 255 patients and caregivers was recruited. A socio-demographic questionnaire was administered to both. The GHQ-12 was used to screen for psychiatric morbidity in the FDRs. Caregiver's burden was assessed with the Zarit Burden Interview. Patients' illness severity and level of functioning were assessed using the Brief Psychiatric Rating Scale and the Global Assessment of Functioning scales respectively. RESULTS: The mean ± SD age of caregivers and patients were 45.1 ±12.3 and 36.7 ±13.4 years respectively. About 49% of caregivers experienced high burden of care. Older caregiver's age (r = 0.179; p < 0.004) and greater illness severity (r = 0.332; p < 0.0001) in the patient had weak to moderate positive correlation with burden of care. Caregiver's burden also increased with poorer functioning of the patient (r = -0.467 p < 0.0001). Independent predictors of caregiver burden were low level of education of the caregiver (OR 2.45; 95% CI 1.27-4.73), psychiatric morbidity in the caregiver (OR 6.74; 95% CI 2.51-18.15) and poor patient functioning (OR 2.81; 95% CI 1.27-6.18). CONCLUSION: Caregivers who are first-degree relatives of patients with schizophrenia experience varying degrees of burden of care during caregiving. Routine screening and early psychological intervention would help to ameliorate these negative consequences of caregiving.