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Three Drug Combinations for Late-Stage Trypanosoma brucei gambiense Sleeping Sickness: A Randomized Clinical Trial in Uganda
Gerardo Priotto, Carole Fogg, Manica Balasegaram, Olema Erphas, Albino Louga, Francesco Checchi, Salah Ghabri, Patrice Piola
PLOS ONE , 2006, DOI: 10.1371/journal.pctr.0010039
Abstract: Objectives Our objective was to compare the efficacy and safety of three drug combinations for the treatment of late-stage human African trypanosomiasis caused by Trypanosoma brucei gambiense. Design This trial was a randomized, open-label, active control, parallel clinical trial comparing three arms. Setting The study took place at the Sleeping Sickness Treatment Center run by Médecins Sans Frontières at Omugo, Arua District, Uganda Participants Stage 2 patients diagnosed in Northern Uganda were screened for inclusion and a total of 54 selected. Interventions Three drug combinations were given to randomly assigned patients: melarsoprol-nifurtimox (M+N), melarsoprol-eflornithine (M+E), and nifurtimox-eflornithine (N+E). Dosages were uniform: intravenous (IV) melarsoprol 1.8 mg/kg/d, daily for 10 d; IV eflornithine 400 mg/kg/d, every 6 h for 7 d; oral nifurtimox 15 (adults) or 20 (children <15 y) mg/kg/d, every 8 h for 10 d. Patients were followed up for 24 mo. Outcome Measures Outcomes were cure rates and adverse events attributable to treatment. Results Randomization was performed on 54 patients before enrollment was suspended due to unacceptable toxicity in one of the three arms. Cure rates obtained with the intention to treat analysis were M+N 44.4%, M+E 78.9%, and N+E 94.1%, and were significantly higher with N+E (p = 0.003) and M+E (p = 0.045) than with M+N. Adverse events were less frequent and less severe with N+E, resulting in fewer treatment interruptions and no fatalities. Four patients died who were taking melarsoprol-nifurtimox and one who was taking melarsoprol-eflornithine. Conclusions The N+E combination appears to be a promising first-line therapy that may improve treatment of sleeping sickness, although the results from this interrupted study do not permit conclusive interpretations. Larger studies are needed to continue the evaluation of this drug combination in the treatment of T. b. gambiense sleeping sickness. Trial Registration ClinicalTrials.gov NCT00330148
Pattern of drug utilization for treatment of uncomplicated malaria in urban Ghana following national treatment policy change to artemisinin-combination therapy
Alexander NO Dodoo, Carole Fogg, Alex Asiimwe, Edmund T Nartey, Augustina Kodua, Ofori Tenkorang, David Ofori-Adjei
Malaria Journal , 2009, DOI: 10.1186/1475-2875-8-2
Abstract: Patients with diagnosis of uncomplicated malaria were recruited from pharmacies of health facilities throughout Accra in a cohort-event monitoring study. The main drug utilization outcomes were the relation of patient age, gender, type of facility attended, mode of diagnosis and concomitant treatments to the anti-malarial regimen prescribed. Logistic regression was used to predict prescription of nationally recommended first-line therapy and concomitant prescription of antibiotics.The cohort comprised 2,831 patients. Curative regimens containing an artemisinin derivative were given to 90.8% (n = 2,574) of patients, although 33% (n = 936) of patients received an artemisinin-based monotherapy. Predictors of first-line therapy were laboratory-confirmed diagnosis, age >5 years, and attending a government facility. Analgesics and antibiotics were the most commonly prescribed concomitant medications, with a median of two co-prescriptions per patient (range 1–9). Patients above 12 years were significantly less likely to have antibiotics co-prescribed than patients under five years; those prescribed non-artemisinin monotherapies were more likely to receive antibiotics. A dihydroartemisinin-amodiaquine combination was the most used therapy for children under five years of age (29.0%, n = 177).This study shows that though first-line therapy recommendations may change, clinical practice may still be affected by factors other than the decision or ability to diagnose malaria. Age, diagnostic confirmation and suspected concurrent conditions lead to benefit:risk assessments for individual patients by clinicians as to which anti-malarial treatment to prescribe. This has implications for adherence to policy changes aiming to implement effective use of ACT. These results should inform education of health professionals and rational drug use policies to reduce poly-pharmacy, and also suggest a potential positive impact of increased access to testing for malaria both within health facil
The epidemiology of malaria in adults in a rural area of southern Mozambique
Alfredo Mayor, John J Aponte, Carole Fogg, Francisco Saúte, Brian Greenwood, Martinho Dgedge, Clara Menendez, Pedro L Alonso
Malaria Journal , 2007, DOI: 10.1186/1475-2875-6-3
Abstract: A cross-sectional survey of 249 adults was conducted in a malaria endemic area of Mozambique. Clinical, parasitological and haematological status of the study population was recorded. Sub-microscopic infections and multiplicity of infections were investigated using polymerase chain reaction (PCR) and restriction fragment length polymorphism of Plasmodium falciparum merozoite surface protein 2 (msp2).Prevalence of P. falciparum infection by microscopy (14%) and PCR (42%) decreased progressively during adulthood, in parallel with an increase in the prevalence of sub-microscopic infections. Anaemia was only related to parasitaemia as detected by PCR. Multiplicity of infection decreased with age and was higher in subjects with high P. falciparum densities, highlighting density-dependent constraints upon the PCR technique.Adults of Manhi?a progressively develop non-sterile, protective immunity against P. falciparum malaria. The method of parasite detection has a significant effect on the observed natural history of malaria infections. A more sensitive definition of malaria in adults should be formulated, considering symptoms such as diarrhoea, shivering and headache, combined with the presence of parasitaemia.The epidemiology of malaria in adults who live in malaria endemic areas is a neglected area of research. Malaria control strategies have focussed on children under the age of 5 years and pregnant women, as the majority of malaria-related sickness and death is seen in these two groups [1]. However, early studies in West Africa showed that clinical attacks of malaria also occur in adults living in areas of high endemicity [2] and a recent report points out the considerable contribution of malaria as a cause of death in adults [3].The risk of malaria attacks in residents of malaria endemic areas falls as they become older [4], suggesting that protection is a function of age. This protective immunity is sequentially being reflected first by a reduction of life-threateni
Supervised versus unsupervised antimalarial treatment with six-dose artemether-lumefantrine: pharmacokinetic and dosage-related findings from a clinical trial in Uganda
Francesco Checchi, Patrice Piola, Carole Fogg, Francis Bajunirwe, Samuel Biraro, Francesco Grandesso, Eugene Ruzagira, Joseph Babigumira, Isaac Kigozi, James Kiguli, Juliet Kyomuhendo, Laurent Ferradini, Walter RJ Taylor, Jean-Paul Guthmann
Malaria Journal , 2006, DOI: 10.1186/1475-2875-5-59
Abstract: Within a trial of supervised versus unsupervised A/L treatment in a stable Ugandan Plasmodium falciparum transmission setting, plasma lumefantrine concentrations were measured in a subset of patients on day 3 (C [lum]day3) and day 7 (C [lum]day7) post-inclusion. Predictors of lumefantrine concentrations were analysed to show how both C [lum]day7 and the weight-adjusted lumefantrine dose affect 28-day recrudescence and re-infection risks. The implications of these novel findings are discussed in terms of the emergence of lumefantrine-resistant strains in Africa.C [lum]day3 and C [lum]day7 distributions among 241 supervised and 238 unsupervised patients were positively skewed. Unsupervised treatment and decreasing weight-adjusted lumefantrine dose were negatively associated with C [lum]day3. Unsupervised treatment and decreasing age showed strong negative associations with C [lum]day7. Both models were poorly predictive (R-squared < 0.25). There were no recrudescences in either arm, but decreasing lumefantrine dose per Kg resulted in up to 13-fold higher adjusted risks of re-infection. Re-infections occurred only among patients with C [lum]day7 below 400 ng/mL (p < 0.001).Maintaining the present six-dose regimen and ensuring high adherence and intake are essential to maximize the public health benefits of this valuable drug combination.The fixed dose antimalarial combination of artemether-lumefantrine (A/L) is a promising and efficacious artemisinin-based combination treatment (ACT) that could play a key role in reducing the high mortality suffered by African children with Plasmodium falciparum malaria. The three day, six dose regimen of A/L is currently prioritized by the World Health Organization as a replacement for failing antimalarial monotherapies, notably chloroquine and sulfadoxine-pyrimethamine (SP). Several countries (e.g. Zambia, Kenya, Tanzania, South Africa, Niger, and Uganda) have now adopted A/L as the first line antimalarial. Clinical trials have shown
Immunogenicity of Fractional Doses of Tetravalent A/C/Y/W135 Meningococcal Polysaccharide Vaccine: Results from a Randomized Non-Inferiority Controlled Trial in Uganda
Philippe J. Guerin ,Lisbeth M. N?ss,Carole Fogg,Einar Rosenqvist,Loretxu Pinoges,Francis Bajunirwe,Carolyn Nabasumba,Ray Borrow,Leif O. Fr?holm,Salah Ghabri,Vincent Batwala,Rogers Twesigye,Ingeborg S. Aaberge,John-Arne R?ttingen,Patrice Piola,Dominique A. Caugant
PLOS Neglected Tropical Diseases , 2008, DOI: 10.1371/journal.pntd.0000342
Abstract: Background Neisseria meningitidis serogroup A is the main causative pathogen of meningitis epidemics in sub-Saharan Africa. In recent years, serogroup W135 has also been the cause of epidemics. Mass vaccination campaigns with polysaccharide vaccines are key elements in controlling these epidemics. Facing global vaccine shortage, we explored the use of fractional doses of a licensed A/C/Y/W135 polysaccharide meningococcal vaccine. Methods and Findings We conducted a randomized, non-inferiority trial in 750 healthy volunteers 2–19 years old in Mbarara, Uganda, to compare the immune response of the full dose of the vaccine versus fractional doses (1/5 or 1/10). Safety and tolerability data were collected for all subjects during the 4 weeks following the injection. Pre- and post-vaccination sera were analyzed by measuring serum bactericidal activity (SBA) with baby rabbit complement. A responder was defined as a subject with a ≥4-fold increase in SBA against a target strain from each serogroup and SBA titer ≥128. For serogroup W135, 94% and 97% of the vaccinees in the 1/5- and 1/10-dose arms, respectively, were responders, versus 94% in the full-dose arm; for serogroup A, 92% and 88% were responders, respectively, versus 95%. Non-inferiority was demonstrated between the full dose and both fractional doses in SBA seroresponse against serogroups W135 and Y, in total population analysis. Non-inferiority was shown between the full and 1/5 doses for serogroup A in the population non-immune prior to vaccination. Non-inferiority was not shown for any of the fractionate doses for serogroup C. Safety and tolerability data were favourable, as observed in other studies. Conclusions While the advent of conjugate A vaccine is anticipated to largely contribute to control serogroup A outbreaks in Africa, the scale-up of its production will not cover the entire “Meningitis Belt” target population for at least the next 3 to 5 years. In view of the current shortage of meningococcal vaccines for Africa, the use of 1/5 fractional doses should be considered as an alternative in mass vaccination campaigns. Trial Registration ClinicalTrials.gov NCT00271479
Individual Differences in the Amount and Timing of Salivary Melatonin Secretion
Helen J. Burgess, Louis F. Fogg
PLOS ONE , 2008, DOI: 10.1371/journal.pone.0003055
Abstract: Background The aim of this study was to examine individual differences in a large sample of complete melatonin profiles not suppressed by light and search for possible associations between the amount and timing of melatonin secretion and a multitude of lifestyle variables. The melatonin profiles were derived from saliva samples collected every 30 minutes in dim light from 85 healthy women and 85 healthy men aged 18–45 years. There was a large individual variability in the amount of melatonin secreted with peak values ranging from 2 to 84 pg/ml. The onset of melatonin secretion ranged from 18:13 to 00:26 hours. The use of hormonal birth control, reduced levels of employment, a smaller number of days on a fixed sleep schedule, increased day length and lower weight were associated with an increased amplitude of melatonin secretion. The use of hormonal birth control, contact lenses, a younger age, and lower ratings of mania and paranoia were associated with a longer duration of melatonin secretion. An earlier occurrence of the onset of melatonin secretion was associated with an earlier wake time, more morningness and the absence of a bed partner. Lifestyle and behavioral variables were only able to explain about 15% of the individual variability in the amount of melatonin secretion, which is likely because of a substantial genetic influence on the levels of melatonin secretion.
International Society for Computational Biology Welcomes Its Newest Class of Fellows
Christiana N. Fogg,Diane E. Kovats
PLOS Computational Biology , 2013, DOI: 10.1371/journal.pcbi.1003199
International Society for Computational Biology Honors David Eisenberg with 2013 Accomplishment by a Senior Scientist Award
Christiana N. Fogg,Diane E. Kovats
PLOS Computational Biology , 2013, DOI: 10.1371/journal.pcbi.1003116
ISMB 2014—The Premier Conference for the World's Computational Biologists
Christiana N. Fogg,Diane E. Kovats
PLOS Computational Biology , 2014, DOI: doi/10.1371/journal.pcbi.1003566
2014 ISCB Accomplishment by a Senior Scientist Award: Gene Myers
Christiana N. Fogg,Diane E. Kovats
PLOS Computational Biology , 2014, DOI: doi/10.1371/journal.pcbi.1003621
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