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Clinical Trial with Secnidazole in a Single Dose in Venezuelan Children Infected by Giardia Intestinalis

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Clinical Trial with Secnidazole in a Single Dose in Venezuelan Children Infected by Giardia Intestinalis Invest Clin 41(3): 179-188, 2000 Clinical trial with Secnidazole in a single dose in venezuelan children infected by Giardia intestinalis. María Cristina Di Prisco1, Juan Carlos Jiménez1, Naima Rodríguez1, Vilma Costa2, Jacqueline Villamizar2, Alexia Silvera2, Mónica Carrillo2, Cleofaf Lira2, Edelmira Zerpa2 and Yesenia López3. 1Instituto de Biomedicina, 3Cátedra de Microbiología, Escuela de Medicina “José María Vargas”, Universidad Central de Venezuela, and 2Ambulatorio Urbano Tipo I, Carapita. Caracas, Venezuela. E-mail: [email protected] Key words: Giardia intestinalis, secnidazole. Abstract. The aim of this work was to evaluate in an open, non- comparative study the use of secnidazole in oral suspension given to Vene- zuelan children infected with Giardia intestinalis, from a community in Carapita, a slum area in Caracas. Seventy children from 2 to 11 years old (38 males and 32 females) were treated with a single oral dose of secnida- zole (30 mg/Kg of body weight), after clinical and parasitological evaluation to make the diagnosis of active giardiasis. The effectiveness of treatment was determined by clinical examination and parasitological evaluation of fe- ces samples 15 days after treatment. The results showed 95% of clinical cure with a significant decrease of the frequency of gastrointestinal symp- toms. The parasitological cure was 98%, there were 4 failures at the end of treatment. Side effects observed after treatment were of mild intensity, last- ing only few hours. These results show that a simple dose of secnidazole in an oral suspension is an effective, safe and well tolerated treatment for giardiasis in children and that this drug may be used as a mass treatment in risk populations. Vol. 41(3): 179-188, 2000 180 Di Prisco y col. Ensayo clínico utilizando una dósis unica de Secnidazol en niños venezolanos infectados por Giardia intestinalis Invest Clín 2000, 41(3): 179-188. Palabras clave: Giardia intestinalis, secnidazol. Resumen. El objetivo de este trabajo fue evaluar mediante un estudio abierto no comparativo el uso de secnidazol en suspensión oral, suminis- trado a niños venezolanos infectados por Giardia intestinalis, procedentes de Carapita, un barrio marginal de la ciudad de Caracas. Setenta niños (38 masculinos y 32 femeninos) con un rango de edad entre2y11años fueron tratados con una dosis única (30mg/Kg peso corporal) de secnidazol, des- pués de haber hecho el diagnóstico de giardiasis mediante examen clínico y evaluación parasitológica en tres muestras de heces. La efectividad del tra- tamiento se determinó 15 días después del tratamiento utilizado la evalua- ción clínica y parasitológica. Los resultados mostraron 95% de cura clínica demostrado por una disminución significativa de la frecuencia de síntomas gastrointestinales. La cura parasitológica fue 98%, hubo cuatro fracasos al final del tratamiento. Los efectos secundarios observados después del trata- miento fueron de moderada intensidad y duraron solamente algunas horas. Estos resultados muestran que una dosis única de secnidazol en una sus- pensión oral es un tratamiento efectivo, seguro y bien tolerado para niños con giardiasis y que esta droga pudiera ser administrada como tratamiento a poblaciones en riesgo. Received: 3-5-2000. Accepted: 25-7-2000. INTRODUCTION may influence the eradication of this parasitosis from their hosts (2, 3). Giardiasis, a worldwide parasito- Immune responses to Giardia sis, that occurs most commonly in intestinalis occur in the intestinal children from sub-tropical and tropi- mucosa and a spectrum of local in- cal regions (1), is produced by a flag- flammatory changes may accom- ellated protozoan, Giardia intestinalis pany this infection. A number of re- that is localized to the small bowel, ports have described the existence where it produces damage to the mu- of allergic symptoms in persons with cosa and gastrointestinal symptoms. giardiasis and the local inflamma- This parasite affects mainly preschool tion may contribute to induce these and school children and it is a public symptoms (4). health problem in tropical countries This infection may cause symp- such as Venezuela. toms such as diarrhoea, abdominal Various immunological and pain, flatulence, and can be associ- non-immunological mechanisms ated with growth retardation (5). The Investigación Clínica 41(3): 2000 Secnidazole treatment in giardiasic children 181 most common treatment in many range from 2 to 11 years old (mean: countries is the use of nitroimida- males 4 ± 2 and females 5 ± 2 years zoles such as metronidazole or tini- old) who attended a program of pri- dazole (6). However, drug resistance mary medical attention in a local has been demonstrated by in vitro medical dispensary of the Venezue- and in vivo studies (7). It has been lan Ministry of Health and Social reported that secnidazole in single Development, in Barrio Carapita, dose treatment could be very effec- Caracas. The children fulfilled the tive in the eradication of giardiasis criteria for inclusion in the study: and amoebiasis (8, 9, 10). Secnida- informed written consent by the zol has also shown a high cure rate parents or legal guardians of the in the treatment of human tricho- children, and the expressed inten- moniasis, amoebiasis and giardiasis tion to participate in all aspects of (11, 12, 13). the study protocol (pre-evaluation, Intestinal parasitic infections are treatment and post-evaluation). The among the most common infections children were clinically examined, in humans, particularly in tropical re- and the accompanying adults were gions, such as Venezuela. The cur- questioned for the existence of gas- rent critical socio-economic condi- trointestinal symptoms suggestive of tions of the majority of the Venezue- giardiasis. Parasitological studies lan population favor these infections, were performed in feces samples therefore we have found a very high from all the children studied. prevalence in Venezuela (14). In the present study we used a Ethical considerations single oral dose of secnidazole to be Because giardiasis is a major administered to giardiasic children public health problem in Venezuela, from a highly parasitized community the tests performed in this study from Carapita, a slum area, in Cara- were offered as part of the routine cas. We describe the results of a program implemented in the medical clinical trial performed as an open dispensary by the paediatric clinic. non-comparative study, in order to We obtained the approval of the verify the effectiveness, tolerance Ethical Committee of the Institute of and safety of this drug given to a Biomedicine, Faculty of Medicine, group of Venezuelan children in- Central University of Venezuela and fected by Giardia intestinalis with or the Medical Board of the dispensary without clinical gastrointestinal in Carapita. symptoms. The principles of these studies were ratified by the Venezuelan Na- MATERIALS AND METHODS tional Council for Scientific and Tec- nological Investigation (CONICIT). Studied patients The informed consent of the le- We evaluated 70 children (38 gal representatives of the children males and 32 females ) with an age was obtained for both the service Vol. 41(3): 179-188, 2000 182 Di Prisco y col. and research components of this single oral dose of secnidazole sus- study, and antiparasite treatment pension, donated by laboratories was administered to all children Rhône-Poulenc Rorer, in Venezuela. found to be infected after the blood The effectiveness of secnidazole was sample had been collected. determined by feces and clinical ex- amination 15 days after treatment. Clinical evaluation After the completion of our study, Clinical evaluation was per- the rest of the children who were not formed by pediatricians who work included in the protocol and were routinely at the medical dispensary found to be infected by any intesti- in Carapita, Caracas. nal parasite were appropriately The clinical history emphasized treated. reports of gastrointestinal symptoms and signs that could be associated Statistical analysis with giardiasis, such as diarrhoea, The data collected were exam- stomach cramps/discomfort, flatu- ined and statistically analysed by lence and vomiting. This clinical the Fisher’s exact and Wilcoxon’s evaluation was performed once before tests. They were considered statisti- treatment, and twice after admini- cally significant when p<0.05. stration of the drug (15 days and 3 months). The results were expressed RESULTS as percentage of children presenting each gastrointestinal symptom. We evaluated the effect of secni- dazole in a simple oral dose given to a Feces examination group of 70 children with an age Parasitological evaluation was range from 2 to 11 years old. Age dis- performed by microscopic examina- tribution is shown in Table I. Chil- tion of three consecutive stool sam- dren attending the paediatric clinic at ples from each child. Samples were this medical dispensary, usually collected into preservative solution show a high frequency of gastrointes- (40% tincture of merthiolate, 5% for- tinal symptoms. The group of chil- malin, and 1% glycerol) and exam- dren evaluated in our study showed ined for the presence of eggs, cysts, abdominal pain 53%, diarrhoea 32 %, or larvae of intestinal parasites. The flatulence 21%, and vomiting 10% all presence of other intestinal para- over the previous 4 weeks. From the sites did not exclude the patient whole group studied, one child was from participation, but specific concomitantly infected with Ascaris treatment for them was given only lumbricoides and three children with after the final evaluation. Blastocystis hominis. The children were treated with Treatment an oral single dose of secnidazole The children were treated with equivalent to 30 mg/Kg of body 30 mg/Kg of body weight used as a weight, and 15 days after treatment, Investigación Clínica 41(3): 2000 Secnidazole treatment in giardiasic children 183 TABLE I AGE DISTRIBUTION OF CHILDREN INFECTED BY GIARDIA INTESTINALIS AND TREATED WITH A SINGLE DOSE OF SECNIDAZOLE (30MG/WEIGHT KG) Age (years) Number of patients (n= 70) Age groups Male Female 2-3 12 11 4-5 20 12 6-7 5 4 8-9 0 3 10-11 1 2 Sub-total 38 32 they were clinically reevaluated.
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