Browsing by Author "Fogg, Carole"

Now showing 1 - 6 of 6
  • Thumbnail Image
    Item
    Adherence to a six-dose regimen of artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in Uganda.
    (The American journal of tropical medicine and hygiene., 2004) Fogg, Carole; Bajunirwe, Francis; Piola, Patrice; Biraro, Samuel; Checchi, Francesco; Kiguli, James; Namiiro, Proscovia; Musabe, Joy; Kyomugisha, Agnes; Guthmann, Jean-Paul
    Measuring baseline levels of adherence and identifying risk factors for non-adherence are important steps before the introduction of new antimalarials. In Mbarara in southwestern Uganda, we assessed adherence to artemether-lumefantrine (Coartem) in its latest World Health Organization blister formulation. Patients with uncomplicated Plasmodium falciparum malaria were prescribed artemether-lumefantrine and received an explanation of how to take the following five doses at home. A tablet count was made and a questionnaire was completed during a home visit. Among 210 analyzable patients, 21 (10.0%) were definitely or probably non-adherent, whereas 189 (90.0%) were probably adherent. Age group was not associated with adherence. Lack of formal education was the only factor associated with non-adherence after controlling for confounders (odds ratio = 3.1, 95% confidence interval [CI] = 1.1-9.7). Mean lumefantrine blood levels were lower among non-adherent (n = 16) (2.76 microg/mL, 95% CI = 1.06-4.45) than among adherent (n = 171) (3.19 microg/mL, 95% CI = 2.84-3.54) patients, but this difference was not statistically significant. The high adherence to artemether-lumefantrine found in our study suggest that this drug is likely to be very effective in Mbarara provided that patients receive clear dosage explanations.
  • Thumbnail Image
    Item
    Assessment of three new parasite lactate dehydrogenase (pan-pLDH) tests for diagnosis of uncomplicated malaria.
    (Transactions of the Royal Society of Tropical Medicine and Hygiene, 2008) Fogg, Carole; Twesigye, Rogers; Batwala, Vincent; Piola, Patrice; Nabasumba, Carolyn; Kiguli, James; Mutebi, Frederick; Hook, Christa; Guillerm, Martine; Moody, Anthony; Guthmann, Jean-Paul
    A study to assess the diagnostic capabilities of three parasite lactate dehydrogenase (pan-pLDH) tests, Vistapan®, Carestart™ and Parabank®, was conducted in Uganda. An HRP2 test, Paracheck-Pf®, and a Giemsa-stained blood film were performed with the pLDH tests for outpatients with suspected malaria. In total, 460 subjects were recruited: 248 with positive blood films and 212 with negative blood films. Plasmodium falciparum was present in 95% of infections. Sensitivity above 90% was shown by two pLDH tests, Carestart (95.6%) and Vistapan (91.9%), and specificity above 90% by Parabank (94.3%) and Carestart (91.5%). Sensitivity decreased with low parasitaemia (χ2 trend, P < 0.001); however, all tests achieved sensitivity >90% with parasitaemia ≥100/μl. All tests had good inter-reader reliability (κ > 0.95). Two weeks after diagnosis, 4–10% of pLDH tests were still positive compared with 69.7% of the HRP2 tests. All tests had similar ease of use. In conclusion, two pLDH tests performed well in diagnosing P. falciparum malaria, and all pLDH tests became negative after treatment more quickly than the HRP2. Therefore the rapid test of choice for use with artemisinin-combination therapies in this area would be one of these new pLDH tests.
  • Thumbnail Image
    Item
    Immunogenicity of Fractional Doses of Tetravalent A/C/Y/W135 Meningococcal Polysaccharide Vaccine: Results from a Randomized Non-Inferiority Controlled Trial in Uganda
    (PLoS neglected tropical diseases, 2008) Guerin, Philippe J.; Næss, Lisbeth M.; Fogg, Carole; Rosenqvist, Einar; Pinoges, Loretxu; Bajunirwe, Francis; Nabasumba, Carolyn; Borrow, Ray; Frøholm, Leif O.; Ghabri, Salah; Batwala, Vincent; Twesigye, Rogers; Aaberge, Ingeborg S.; Røttinge, John-Arne; Piola, Patrice; Caugan, Dominique A.
    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. 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 favorable, as observed in other studies. 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.
  • Thumbnail Image
    Item
    Pharyngeal carriage of Neisseria meningitidis in 2–19-year-old individuals in Uganda
    (Transactions of The Royal Society of Tropical Medicine and Hygiene, 2006) Caugant, Dominique A.; Fogg, Carole; Bajunirwe, Francis; Piola, Patrice; Twesigye, Rogers; Mutebi, Fred; Frøholm, L. Oddvar; Rosenqvist, Einar; Batwala, Vincent; Aaberge, Ingeborg S.; Rottingen, John-Arne; Guerin, Philippe J.
    In southern Uganda, only sporadic cases of serogroup A meningococcal disease have been reported since 2000. As part of an immunogenicity study of the tetravalent meningococcal polysaccharide vaccine, nasopharyngeal swab samples were collected twice, 4 weeks apart, from 2–19-year-old healthy individuals in Mbarara, Uganda. Only 15 (2.0%) of the 750 individuals carried meningococci asymptomatically. Most of the strains were non-serogroupable and none were serogroup A. However, two individuals carried a serogroup W135 strain, sequence type (ST)-11, similar to the clone that was responsible for the epidemic in Burkina Faso in 2002. Our study further demonstrates the geographical spread of serogroup W135 ST-11 strain and thus the potential epidemic risk.
  • Thumbnail Image
    Item
    Pharyngeal carriage of Neisseria meningitidis in 2—19-year-old individuals in Uganda
    (Transactions of the Royal Society of Tropical Medicine and Hygiene, 2006) Caugant, Dominique A.; Fogg, Carole; Bajunirwe, Francis; Piola, Patrice; Guerin, Philippe J.; Twesigye, Rogers; Mutebi, Fred; Frøholm, L. Oddvar; Rosenqvist, Einar; Batwala, Vincent; Aaberge, Ingeborg S.; Rottingen, John-Arne
    In southern Uganda, only sporadic cases of serogroup A meningococcal disease have been reported since 2000. As part of an immunogenicity study of the tetravalent meningococcal polysaccharide vaccine, nasopharyngeal swab samples were collected twice, 4 weeks apart, from 2—19-year-old healthy individuals in Mbarara, Uganda. Only 15 (2.0%) of the 750 individuals carried meningococci asymptomatically. Most of the strains were non-serogroupable and none were serogroup A. However, two individuals carried a serogroup W135 strain, sequence type (ST)-11, similar to the clone that was responsible for the epidemic in Burkina Faso in 2002. Our study further demonstrates the geographical spread of serogroup W135 ST-11 strain and thus the potential epidemic risk.
  • Thumbnail Image
    Item
    Supervised Versus Unsupervised Intake Of Six-Dose Artemether-Lumefantrine For Treatment Of Acute, Uncomplicated Plasmodium Falciparum Malaria In Mbarara, Uganda: A Randomised Trial
    (The Lancet, 2005) Piola, Patrice; Fogg, Carole; Bajunirwe, Francis; Biraro, Samuel; Grandesso, Francesco; Ruzagira, Eugene; Babigumira, Joseph; Kigozi, Isaac; Kiguli, James; Kyomuhendo, Juliet; Ferradini, Laurent; Taylor, Walter; Checchi, Francesco; Guthmann, Jean-Paul
    The six-dose regimen of artemether-lumefantrine is effective and is among combination therapies prioritised to replace antimalarials that no longer work in Africa. However, its effectiveness has not been assessed in the field, and could be compromised by poor adherence, incorrect timing of doses, and insufficient intake of fatty foods with every dose. Our aim, therefore, was to assess the effectiveness of artemether-lumefantrine prescribed under routine outpatient conditions, compared with its efficacy when given under supervision to inpatients with acute uncomplicated falciparum malaria.We did a randomised trial to compare the efficacy, safety, and pharmacokinetics of artemether-lumefantrine when given in a supervised (all doses observed with fatty-food intake; n=313) or unsupervised (first dose supervised followed by outpatient treatment with nutritional advice; n=644) setting to patients of all ages (weight >10 kg) with acute, uncomplicated falciparum malaria in Mbarara, Uganda. Our primary endpoint was 28 day, PCR-adjusted, parasitological cure rate. Analysis was by intention to treat and evaluability analysis.38 patients were lost to follow-up and one withdrew consent. Day-28 cure rates were 97·7% (296 of 303) and 98·0% (603 of 615) in the supervised and unsupervised groups, respectively. We recorded 15 non-severe, drug-related adverse events, all of which resolved.Artemether-lumefantrine has a high cure rate irrespective of whether given under supervision with food or under conditions of routine clinic practice. If used as first-line treatment, artemether-lumefantrine could make a substantial contribution to malaria control in Africa, though cost is an issue.