An observational study in Malaria and Filariasis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in Mali. Open to participants aged 1 Year to 20 Years. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
This study will examine the clinical, immunological and epidemiological effects of concurrent infections with P. falciparum and W. bancrofti or M. perstans (the parasites that cause malaria and filariasis) on the frequency and severity of malaria infection in children and young adults in Mali, Africa.
Residents of Tien gu bougou and Bougoudiana, Mali, who are between 1 and 20 years of age may be eligible for this study. Participants with and without filarial infection will be enrolled.
Participants undergo the following tests and procedures:
Residents of malaria-endemic regions are frequently exposed to a variety of other parasites concurrently with malarial parasites. In Mali, lymphatic filariasis due to Wuchereria bancrofti co-exists in several regions highly endemic for malaria, and co-infection is common in the residents of these areas. Because of the chronicity of filarial infections and an associated bias towards the development of an adaptive immune response dominated by Th2 cytokines, a pre-existing filarial infection has the potential to alter the immune response towards incoming malarial parasites, clearance of which are considered to be dependent on a robust Th1 response. This could, in turn, affect the clinical manifestations and outcomes of malaria infection. Conversely, immune responses to filarial parasites may be modulated in the presence of malarial parasites. In addition to sharing a human host, Plasmodium falciparum and Wuchereria bancrofti are transmitted by the same mosquito vector, Anopheles gambiae, and interaction between the two species in the vector may have important implications for transmission of these two infections. The primary goals of this study are to determine the effect of concurrent infections with P. falciparum and W. bancrofti parasites on the prevalence and severity of malaria infection in children living in a Malian village co-endemic for two parasites and to assess the effects of co-infection on the immune responses to these two parasites over the course of the malaria transmission season. The epidemiology of co-infection at the human and vector level will also be examined.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 1,039 is above the median of 582 across 204 observational studies indexed under Malaria.
Browse Malaria studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Age 1 - 20 years
Male or non-pregnant female
Resident of Tien gu bougou or Bougoudiana
EXCLUSION CRITERIA (Screening):
History or clinical evidence of severe and/or chronic illness
History of allergy to artesunate, amodiaquine, albendazole, praziquantel or mebendazole
Plans to relocate outside the immediate vicinity of the village during the study period
INCLUSION CRITERIA (Matched prospective study):
Age 1 - 20 years
Male or non-pregnant female
Resident of Tien gu bougou or Bougoudiana
EXCLUSION CRITERIA (Matched prospective study):
History or clinical evidence of severe and/or chronic illness
History of allergy to artesunate, amodiaquine, albendazole, praziquantel or mebendazole
Plans to relocate outside the immediate vicinity of the village during the study period
less than or equal to 8 g/dL
Symptoms of malaria with parasitemia greater than or equal to 100,000/microliters at enrollment
Recent history or clinical evidence of prostration, bleeding, respiratory distress, seizures, coma or obtundation, jaundice, inability to drink, persistent vomiting
INCLUSION CRITERIA: (Immunologic Extension Study)
Age > 10 years
Male or non-pregnant female (by history)
Resident of Tien gu bougou or Bougoudiana
Willingness to allow storage of specimens for future research
EXCLUSION CRITERIA: (Immunologic Extension Study)
History or clinical evidence of severe and/or chronic illness
Hemoglobin less than or equal to g/dL
Positive pregnancy test
Clinical malaria (symptoms of malaria plus any malaria parasites identified on thick smear)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The record gives a start of May 2007 and a completion of Jan 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institute of Allergy and Infectious Diseases (NIAID) →